Baby Move [Discontinued] by Wellements Baby

POSSIBLY EFFECTIVE

• Atopic dermatitis (eczema). In infants at risk for atopy, providing syrup or formula containing GOS along with probiotics or fructo-oligosaccharides may reduce the risk of developing atopic dermatitis. Details: One large clinical trial in infants at high risk for allergies shows that feeding 20 drops of syrup containing GOS 0.8 grams, in combination with one opened capsule of probiotic bacteria, daily for 6 months reduces the incidence of dermatitis and atopic dermatitis by the age of 2 years when compared with placebo (26707). It is unclear if these findings are due to GOS, probiotics, or the combination, especially since mothers in the treatment group also took probiotics for 2-4 weeks before delivery. Also, a small clinical trial in newborns at risk for atopic disease shows that feeding a formula containing a combination of GOS and fructo-oligosaccharides 8 grams/L as often as necessary for 6 months reduces the risk, but not severity, of developing atopic dermatitis when compared with placebo formula (26708). At 2 years of age, the infants given this formula were half as likely to have developed atopic dermatitis (99223). However, in one study in healthy formula-fed infants, formula containing 4 grams/L of GOS and polydextrose (1:1 ratio) given as often as necessary for approximately 4 months increased the potential of developing atopic dermatitis as an adverse effect by up to 11% when compared with control formula (26709).
• Colic. Providing formula containing GOS and other ingredients may reduce the duration or frequency of crying episodes in infants with colic. Details: One clinical trial in infants with colic shows that feeding a formula containing 8 grams/L of a prebiotic mixture of GOS 90% and fructo-oligosaccharides 10% as often as necessary for 14 days reduces the number of colic episodes when compared with a control formula plus simethicone 6 mg/kg twice daily (26710). Another clinical trial in healthy infants 14-35 days of age shows that feeding a cow's milk-based formula containing 4 grams/L of a prebiotic blend of GOS and polydextrose (1:1 ratio) until around 4 months of age leads to faster normalization of daytime sleep patterns when compared with cow's milk-based formula alone. Episodes of crying were also shorter after 2 months, but not 4 months, of supplementation (106527). It is unclear if the findings from this study in healthy infants can be generalized to those with colic.
• Lactose intolerance. Oral GOS may improve some symptoms of lactose intolerance and allow for increased consumption of lactose-containing products, even after discontinuing GOS. Details: Although a small clinical study found no effect with the use of GOS (99224), one large clinical study in patients with lactose intolerance shows that taking GOS titrated up to 7.5-10 grams twice daily for 30 days improves overall symptoms of lactose intolerance, and in particular cramping and bloating, when compared with placebo (106526). Patients in these studies were asked to avoid lactose-containing products during the treatment period, so the effect of GOS on symptoms in patients actively consuming lactose products is unclear. After the study period, patients were asked to reintroduce lactose products into their diets. Those that had been taking GOS in both studies reported increased milk intake and fewer symptoms when compared with those previously treated with placebo, suggesting that the effects of GOS continue after discontinuation (99224,106526).

POSSIBLY INEFFECTIVE

• Allergic rhinitis (hay fever). Supplementation with oral GOS during the first 6 months of life may not prevent the development of allergic rhinitis in infants at risk for allergies. Details: One large clinical trial in infants at risk for allergies shows that feeding 20 drops of syrup containing GOS 0.8 grams, in combination with one opened capsule of probiotic bacteria, daily for 6 months does not reduce the risk of developing allergic rhinitis by the age of 2 years when compared with placebo (26707).
• Food allergies. Supplementation with oral GOS during the first 6-12 months of life may not prevent the development of food allergies at 1 or 2 years of age. Details: One large clinical trial in infants at risk for allergies shows that feeding 20 drops of syrup containing GOS 0.8 grams, in combination with one opened capsule of probiotic bacteria, daily for 6 months does not reduce the risk of developing food allergies by the age of 2 years when compared with placebo (26707). Another large clinical study in healthy, full-term infants shows that feeding a formula containing GOS 4.4-5 grams/L from 8 weeks of age until 12 months of age does not reduce the incidence of allergic sensitization to foods, based on skin prick testing, when compared with placebo (99218).
• Upper respiratory tract infection (URTI). Large studies suggest that oral GOS do not prevent the development of URTIs in healthy infants or young adults. It is unclear if GOS are beneficial for the prevention of URTIs in premature infants. Details: A large clinical study in healthy, term infants shows that feeding a formula containing GOS 4.4-5 grams/L from before 8 weeks of age until 12 months of age does not reduce the incidence of URTIs (99218). Also, a large clinical trial in healthy university students going through exam-related stress shows that taking GOS (Purimmune, GTC Nutrition) 2.5 or 5 grams daily for 8 weeks does not reduce the total number of cold or flu symptoms when compared with placebo (99221). GOS, in combination with polydextrose, has been evaluated in premature infants. A small clinical trial shows that feeding a 1:1 combination of these at a dose of 600-1200 mg daily during the first 60 days of life reduces the incidence of URTIs, including the common cold, when compared with placebo. However, this prebiotic combination does not seem to reduce the duration or severity of respiratory tract infections that do occur (99211). It is unclear if any effects are due to GOS, polydextrose, or the combination.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anxiety. It is unclear if oral GOS are beneficial in patients with anxiety. Details: One small clinical study in healthy females 18-25 years of age shows that taking GOS 5.5 grams daily for 4 weeks does not improve anxiety scores overall or in subgroups of individuals reporting high or low baseline levels of anxiety when compared with placebo (106640).
• Asthma. It is unclear if GOS, alone or in combination with fructo-oligosaccharides, are beneficial for preventing the development of asthma or recurrent wheeze in infants at risk for allergies. Details: One large clinical study in infants at risk for allergies shows that feeding 20 drops of syrup containing GOS 0.8 grams, in combination with one opened capsule of probiotic bacteria, daily for 6 months does not reduce the risk of developing atopic disease, including asthma, by the age of 2 years when compared with placebo (26707). However, another large clinical study in newborns at risk for atopic disease shows that feeding a formula containing a combination of GOS and fructo-oligosaccharides 8 grams/L as often as necessary for 6 months reduces the risk of developing recurrent wheezing, a risk factor for asthma, by 2 years of age when compared with placebo. Approximately 8% of infants given GOS formula developed recurrent wheeze, compared to about 21% of those given placebo formula (99223). These discrepant findings may be due to differences in measured outcomes, as well as the doses and products studied.
• Colorectal cancer. Although there has been interest in using oral GOS for the prevention of colorectal cancer, there is insufficient reliable information about the clinical effects of GOS for this purpose.
• Constipation. It is unclear if oral GOS, when taken with water or added to yogurt, are beneficial in patients with constipation. Details: Preliminary clinical research in adults with constipation shows that taking a specific GOS product (Biotis GOS, Friesland Campina) orally as 5.5-11 grams daily for three weeks does not increase stool frequency when compared with placebo (107730). Similarly, one very small clinical study in elderly females with constipation shows that consuming yogurt containing a specific syrup (Elix'or, Borculo Domo Ingredients) providing GOS 4.5 grams twice daily for 2 weeks does not improve defecation frequency, laxative use, or ease of defecation when compared with placebo (26706). Another small clinical study in elderly patients with mild constipation shows that consuming yogurt containing GOS 12 grams, prunes 12 grams, and linseed 6 grams daily for 3 weeks increases the frequency and ease of defecation and improves relief when compared with a traditional yogurt in elderly patients with mild constipation (21191). However, it is unclear if these findings are due to GOS, other ingredients, _or the combination.
• Depression. It is unclear if oral GOS are beneficial in patients with depression. Details: One small clinical trial in patients with major depressive disorder shows that taking GOS 5 grams daily for 8 weeks does not improve symptoms of depression when compared with placebo, and appears to be less effective when compared with a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum (102506).
• Diarrhea. Although there has been interest in using oral GOS for the prevention and treatment of diarrhea, including travelers' diarrhea, there is insufficient reliable information about the clinical effects of GOS for this purpose.
• Insomnia. Oral GOS have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: One small crossover trial in adults with sleep disturbances shows that taking a combination product containing GOS 5.2 grams, whey protein 9.5 grams, large neutral amino acids 3.4 grams, and other vitamins and minerals one hour before bed nightly for 3 weeks does not improve sleep quality when compared with a control product containing no GOS and smaller amounts of protein, amino acids, vitamins, and minerals (106528).
• Iron deficiency anemia. GOS increases the absorption and tolerability of iron supplements, and may therefore be beneficial in patients with iron deficiency anemia. Details: Preliminary clinical research shows that taking GOS with iron supplements increases the absorption and tolerability of iron (102509,102510,107729). One small clinical trial in adult females shows that taking GOS 15 grams orally as a single dose increases the fractional iron absorption from oral ferrous sulfate, containing 104 mg iron, by 45% when compared with control (107729). Other clinical research in young, iron-deficient females, shows that giving GOS 963 mg/kg in addition to ferrous sulfate 30 ppm, increases mean hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, serum iron, serum transferrin, and total iron binding capacity when compared with ferrous sulfate alone (110599).
• Irritable bowel syndrome (IBS). It is unclear if oral GOS are beneficial in patients with IBS. Details: One small clinical trial in patients with IBS shows that taking GOS 1.4 grams daily while following a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) for 4 weeks increases the odds of adequate IBS symptom relief by 4.6-fold when compared with placebo plus a sham diet. However, no difference in rate of adequate symptom relief was reported when GOS plus the low FODMAP diet were compared with placebo plus the low FODMAP diet, suggesting that any benefits may have been due to the diet (106525).
• Metabolic syndrome. It is unclear if oral GOS are beneficial in patients with metabolic syndrome. Details: A small clinical study in overweight patients with metabolic syndrome shows that taking GOS 5.5 grams daily for 12 weeks does not improve most measures of metabolic syndrome when compared with placebo. Although levels of total cholesterol, triglycerides, and insulin were reduced by a small amount, these changes were not clinically meaningful (99219).
• Neonatal jaundice. It is unclear if oral GOS are beneficial for the treatment of neonatal jaundice. Details: A small clinical study in healthy infants with mild hyperbilirubinemia shows that providing a formula containing a combination of GOS and fructo-oligosaccharides 8 grams/L as often as necessary for 28 days reduces levels of bilirubin within 72 hours when compared with those given placebo formula. Whether GOS can reduce bilirubin levels in infants with very high levels of bilirubin is unknown, as these infants were excluded from this study (99222).
• Obesity. It is unclear if oral GOS improves weight loss in overweight or obese adults. Details: A small clinical study in overweight adults shows that taking GOS 6 grams, 12 grams, or 18 grams daily in oolong tea for 2 weeks has a small effect on appetite and weight loss when compared with oolong tea alone. Weight loss of 0.1-0.2 kg occurred over the study period, compared with no change in those taking oolong tea alone (99217).
• Osteoporosis. Although there has been interest in using oral GOS for osteoporosis, there is insufficient reliable information about the clinical effects of GOS for this purpose.
• Prematurity. It is unclear if oral GOS are beneficial for improving cognitive or motor development in premature infants. Details: A small clinical study in premature infants shows that adding a combination of GOS, fructo-oligosaccharides, and pectin acidic oligosaccharides up to 1.5 grams/kg daily to breast milk or formula for 30 days after birth does not improve cognitive or motor development outcomes at the age of 2 years when compared with placebo (99216).
• Ulcerative colitis. It is unclear if oral GOS are beneficial in patients with ulcerative colitis. Details: Preliminary clinical research in adults with ulcerative colitis shows that taking a specific GOS product (Bimuno GOS, Clasado Biosciences) orally 2.8 grams daily for 6 weeks does not increase clinical remission or improve IBD severity scores when compared with baseline. However, subgroup analyses suggest that taking GOS may reduce the frequency and urgency of loose stools. The validity of this study is limited by the lack of a comparator group (107728).
• Urticaria. It is unclear if oral GOS are beneficial for the prevention of urticaria in infants. Details: A small clinical study in newborns at risk for atopic disease shows that feeding a formula containing a combination of GOS and fructo-oligosaccharides 8 grams/L as often as necessary for 6 months reduces the risk of developing urticaria at 2 years of age when compared with placebo. Approximately 1.5% of infants in the GOS group developed urticaria, compared to 10.3% of those in the placebo group (99223). More evidence is needed to rate GOS for these uses.

(Read more about GALACTO-OLIGOSACCHARIDES (GOS))

LIKELY SAFE ...when consumed in amounts commonly found in foods. GOS are found in various foods, including dairy products, legumes, and some root vegetables (26702,26732).

POSSIBLY SAFE ...when used orally and appropriately, short-term. GOS or foods fortified with GOS up to 20 grams daily have been safely used in clinical research for up to 30 days (21191,26706,26712,26727,99224,106526,106529,107715,107729). The European Food Safety Authority has concluded that consuming food products providing GOS up to 16.2 grams daily does not present safety concerns (106530). This agency has not evaluated the safety of higher doses in food products.

CHILDREN: POSSIBLY SAFE
when used orally in breast milk or infant formulas containing up to 7. 2 grams/L of GOS provided as the sole prebiotic or in combination with other prebiotics, including fructo-oligosaccharides or polydextrose, daily for 4-12 months (26708,26709,26710,26720,99211,99212,99215,99218,99222,99223,106527). ...when used in doses of up to 10 grams daily for 3 weeks in females 10-13 years of age (99210).

PREGNANCY AND LACTATION: LIKELY SAFE
when consumed in amounts commonly found in foods.

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally. GOS have been safely used in clinical research in doses of about 4.5 grams daily from week 25 of pregnancy until delivery (26721).

(Read more about GALACTO-OLIGOSACCHARIDES (GOS))

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, GOS might reduce the effects of immunosuppressants.  Details Human and animal studies suggest that GOS may stimulate the immune system (26711,26723). This could theoretically alter the effects of immunosuppressant medications.

(Read more about GALACTO-OLIGOSACCHARIDES (GOS))

General ...Orally, GOS seem to be well tolerated in infants, children, and adults.
Most Common Adverse Effects:
Orally: Bloating, constipation, diarrhea, flatulence, and increased stool frequency.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Dermatologic ...Orally, giving a formula supplemented with 4 grams/L of GOS and polydextrose (1:1 ratio) to infants has been associated with an increased incidence of atopic dermatitis in one clinical study (26709). However, most other clinical research in infants at risk of atopy shows that GOS-containing formula may actually reduce the risk of developing atopic dermatitis (26707,26708,99223).

Gastrointestinal ...Orally, galacto-oligosaccharides may cause bloating, flatulence, and increased stool frequency (26706,26709,26724,99217,99222). Giving a formula supplemented with 4 grams/L of GOS and polydextrose (1:1 ratio) to infants has been associated with an increased incidence of gastrointestinal adverse effects, primarily constipation and diarrhea, in one clinical study (106527). However, it is unclear if this was due to GOS, polydextrose, or the combination.

Immunologic ...Orally, GOS have been rarely associated with allergic reactions, including anaphylaxis. Research in these patients shows that people who are previously sensitized to Blomia tropicalis, a common dust mite in Southeast Asia, may also experience allergic reactions after consumption of GOS. Blomia tropicalis contains glycosylated allergens that have IgE mediated cross-reactivity to GOS (102508).

Psychiatric ...Orally, giving infants a formula supplemented with 8 grams/L of a 50:33:17 mixture of polydextrose, GOS, and lactulose has been associated with increased infant irritability when compared with control formula (26709). However, it is not known if this was related to the GOS, other ingredients, or the combination. An increase in irritability did not occur in infants given a formula supplemented with 4 grams/L of polydextrose and GOS (1:1 ratio) (26709,106527).

(Read more about GALACTO-OLIGOSACCHARIDES (GOS))