There is insufficient evidence to recommend for or against the use of synbiotics to prevent or treat common gastrointestinal (GI) disorders in infants and children.
That’s the conclusion of a position paper from the European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) special interest group on gut microbiota and modifications and its working group for pre- and probiotics.
Based on their review of available data, the group could not offer a recommendation on use of any specific synbiotic preparation for treatment of acute gastroenteritis, Helicobacter pylori (H pylori) infection, inflammatory bowel disease (IBD), infantile colic, functional abdominal pain, irritable bowel syndrome (IBS), or constipation.
No recommendation can be formulated on their use in the prevention of food allergies, the group also says.
The same goes for prevention of necrotizing enterocolitis (NEC) in preterm infants and newborns with cyanotic congenital heart disease, as well as prevention of food allergies.
The position paper was published online in the Journal of Pediatric Gastroenterology and Nutrition.
Few Studies, Major Limitations
A synbiotic mixture comprises probiotics and prebiotics selectively utilized by host microorganisms that confers a health benefit on the host.
While the number of studies evaluating the effect of different synbiotics is increasing, the results to date are “ambiguous,” report first author Iva Hojsak, with Children’s Hospital Zagreb, Croatia, and colleagues. Well-designed studies using the same outcome measures for specific clinical indications are needed to allow comparison between studies, they write.
To gauge their effect on pediatric GI disorders, the group searched the literature for studies in English that compared the use of synbiotics, in all delivery vehicles and formulations, at any dose, with no synbiotic (placebo or no treatment or other interventions).
They found very few studies that addressed the specific indications of interest, ranging from two randomized controlled trials (RCTs) each for infantile colic and IBD to five RCTs for acute gastroenteritis.
There were only two indications (acute gastroenteritis and H pylori) where two synbiotic preparations were tested.
The studies often included a limited number of participants, had significant methodological biases, scarcely reported on side effects or adverse events, and reported different outcomes, making inter-study comparisons tough.
“Comparison of studies was further limited by the synbiotic preparation used, where dose effect was not assessed,” the group writes. Also, few studies used the same synbiotic preparation for a specific clinical indication or the same amount of live bacteria and prebiotic in the preparation.
The authors made note of the newly stringent recommendations for direct evidence proposed by the International Scientific Association for Probiotics and Prebiotics, which state RCTs need to compare the synergistic synbiotic combination, the substrate alone, the live microorganisms alone, and a control.
Outside Experts Weigh In
Offering outside perspective for Medscape Medical News, Gail Cresci, PhD, microbiome researcher, Department of Pediatric Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic Children’s Hospital, said what’s “most notable with this review is that there is an issue with studies that incorporate a prebiotic and probiotic in that there is much heterogeneity with the probiotic strains and prebiotic substrates that are investigated.”
Cresci also noted that “both pre- and probiotics have specific mechanisms of action based on the substrate and strain, respectively, so to pull the trials together and analyze as a ‘synbiotic’ treating all the combinations the same is not accurate [and] also limits the ability to do meta-analyses and make recommendations in a position paper.”
Geoffrey Preidis, MD, PhD, spokesperson for the American Gastroenterological Association (AGA), also reviewed the paper for Medscape Medical News.
He noted that few studies tested the exact same synbiotic preparation for a given clinical indication.
“For the majority of GI disorders examined in this review, the total number of studies testing a particular synbiotic formulation is exactly one. Clinical recommendations rarely can be made based on the results of a single trial,” said Preidis, a pediatric gastroenterologist with Texas Children’s Hospital in Houston.
“Perhaps most importantly, most studies do not report safety data as rigorously as these data are reported in pharmaceutical trials, so the risk of side effects could be higher than we think,” he noted.
“Millions of Americans take probiotics. They are the third most commonly used dietary supplement behind vitamins and minerals,” Preidis added. “Prebiotics and synbiotics also are increasing in popularity. They can be found almost everywhere — in supermarkets, drugstores, health food stores, and online — in pill or powder form and in some foods and beverages.
“None of these products have been approved by the [US Food and Drug Administration] to treat, cure, or prevent any disease. In most circumstances, there is not enough clinical evidence to suggest a clear value to be gained for most consumers,” he said.
Preidis said he agrees with the conclusions of this “thoughtfully written position paper” on whether synbiotics have a role in the management of GI disorders in children.
“Synbiotics should not be given routinely to infants or children to manage GI disorders at this time,” he told Medscape Medical News. “Potential beneficial effects are not yet confirmed in multiple well-designed, adequately powered trials that test the same synbiotic combination and dose, measure the same outcomes, and rigorously document all adverse effects.”
This research had no specific funding. Hojsak received payment/honorarium for lectures from BioGaia, Nutricia, Biocodex, AbelaPharm, Nestle, Abbott, Sandoz, Oktal Pharma, and Takeda. Cresci and Preidis report no relevant disclosures.
J Pediatr Gastroenterol Nutr. Published online July 28, 2022. Full text.
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