Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials

Almutairi, Rawan; Basson, Abigail R.; Wearsh, Pamela; Cominelli, Fabio; Rodriguez-Palacios, Alexander

doi:10.1007/s00394-022-02802-5

Cited by 23 publications

(12 citation statements)

References 109 publications

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“…It is additionally worth noting that placebos are difficult to design for microbiome clinical trials; for example, maltodextrin placebos (like the one used here) may have an impact on the gut microbiota, yielding a placebo response rate and raising the difficulty of observing a statistically significant response in the active group. 53,54 Despite these limitations, however, we still observed a statistically significant response to treatment when considering the constipated cohorts, whereas non-constipated individuals taking the intervention experienced no significant change in WBMs as a function of treatment.…”

Section: Discussionmentioning

confidence: 67%

Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial

et al. 2022

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Background Oral microbial therapy has been studied as an intervention for a range of gastrointestinal disorders. Though research suggests that microbial exposure may affect the gastrointestinal system, motility, and host immunity in a pediatric population, data have been inconsistent, with most prior studies being in neither a randomized nor placebo-controlled setting. The aim of this randomized, placebo-controlled study was to evaluate the efficacy of a synbiotic on increasing weekly bowel movements (WBMs) in constipated children. Methods Sixty-four children (3–17 years of age) were randomized to receive a synbiotic (n = 33) comprising mixed-chain length oligosaccharides and nine microbial strains, or placebo (n = 31) for 84 days. Stool microbiota was analyzed on samples collected at baseline and completion. The primary outcome was a change from baseline of WBMs in the treatment group compared to placebo. Results Treatment increased (p < 0.05) the number of WBMs in children with low baseline WBMs, despite broadly distinctive baseline microbiome signatures. Sequencing revealed that low baseline microbial richness in the treatment group significantly anticipated improvements in constipation (p = 0.00074). Conclusions These findings suggest the potential for (i) multi-species-synbiotic interventions to improve digestive health in a pediatric population and (ii) bioinformatics-based methods to predict response to microbial interventions in children. Impact Synbiotic microbial treatment improved the number of spontaneous weekly bowel movements in children compared to placebo. Intervention induced an increased abundance of bifidobacteria in children, compared to placebo. All administered probiotic species were enriched in the gut microbiome of the intervention group compared to placebo. Baseline microbial richness demonstrated potential as a predictive biomarker for response to intervention.

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Section: Discussionmentioning

confidence: 67%

Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial

et al. 2022

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“…It is additionally worth nothing that placebos are difficult to design for microbiome clinical trials; for example, maltodextrin placebos (like the one used here) may have an impact on the gut microbiota, yielding a placebo response rate and raising the difficulty of observing a statistically significant response in the active group. 51,52 Despite these limitations, however, we still observed a statistically significant response to treatment when considering the constipated cohorts, whereas non-constipated individuals taking the intervention experienced no significant change in WBMs as a function of treatment.…”

Section: Discussionmentioning

confidence: 71%

Functional response to a microbial synbiotic in the gastrointestinal system of constipated children

Tierney

Versalovic

Fasano

et al. 2022

Preprint

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Background: Oral microbial therapy has been studied as an intervention for a range of gastrointestinal and immunological disorders. Though emerging research suggests microbial exposure may intimately affect the gastrointestinal system, motility, and host immunity in a pediatric population, data has been inconsistent and variable, with the majority of prior studies conducted in neither a randomized nor placebo-controlled setting. The aim of this placebo-controlled study was to evaluate efficacy of a synbiotic (a prebiotic and rationally-defined microbial consortia) on increasing weekly bowel movement frequency in constipated children. Methods: Sixty-four children (3-17 years of age) were randomized to receive a synbiotic composition (n=33) comprised of mixed-chain length, prebiotic oligosaccharides and nine microbial strains or placebo (n=31) for 84 days. Stool microbiota was analyzed using shotgun metagenomic sequencing on samples collected at baseline (T1) and completion (T2). The primary outcome was change from baseline of Weekly Bowel Movements (WBMs) in children compared to placebo. Results: Treatment with a multi-strain synbiotic significantly (p < 0.05) increased the number of WBMs in children with low bowel movement frequency (< 4 WBMs and < 5 WBMs), irrespective of broadly distinctive microbiome signatures at baseline. Metagenomic shotgun sequencing revealed that low baseline microbial richness in the treatment group significantly anticipated improvements in constipation (p = 0.00074). Conclusions: These findings suggest the potential for (i) multi-species synbiotic interventions to improve digestive health in a pediatric population and (ii) bioinformatics-based methods to predict response to microbial interventions in children. Impact: Synbiotic microbial treatment exerted functional improvements in the number of spontaneous Weekly Bowel Movements in children compared to placebo. Intervention induced a significant bifidogenic effect in children compared to placebo. All administered probiotic species were enriched in the gut microbiome of the intervention group compared to placebo. Baseline microbial richness demonstrated potential as a predictive biomarker for response to intervention.

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“…Two reviews 38 , 39 and 43 individual studies 105–134 , 152 , 153 reported an association between microbiota and an emulsifier, thickener, stabilizer, preservative, flavoring, sweetener or food coloring (Supplementary Table S7). A high proportion of studies investigating the effects of food additives on the gut microbiota have been animal 38 , 118 or in vitro studies, 106 , 130 with human studies conducted to date being disease-specific.…”

Section: Resultsmentioning

confidence: 99%

Diet-microbiota associations in gastrointestinal research: a systematic review

Duncanson,

Williams,

Hoedt

et al. 2024

Gut Microbes

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Interactions between diet and gastrointestinal microbiota influence health status and outcomes. Evaluating these relationships requires accurate quantification of dietary variables relevant to microbial metabolism, however current dietary assessment methods focus on dietary components relevant to human digestion only. The aim of this study was to synthesize research on foods and nutrients that influence human gut microbiota and thereby identify knowledge gaps to inform dietary assessment advancements toward better understanding of diet–microbiota interactions. Thirty-eight systematic reviews and 106 primary studies reported on human diet-microbiota associations. Dietary factors altering colonic microbiota included dietary patterns, macronutrients, micronutrients, bioactive compounds, and food additives. Reported diet-microbiota associations were dominated by routinely analyzed nutrients, which are absorbed from the small intestine but analyzed for correlation to stool microbiota. Dietary derived microbiota-relevant nutrients are more challenging to quantify and underrepresented in included studies. This evidence synthesis highlights advancements needed, including opportunities for expansion of food composition databases to include microbiota-relevant data, particularly for human intervention studies. These advances in dietary assessment methodology will facilitate translation of microbiota-specific nutrition therapy to practice.

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Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials

Cited by 23 publications

References 109 publications

Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial

Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial

Functional response to a microbial synbiotic in the gastrointestinal system of constipated children

Diet-microbiota associations in gastrointestinal research: a systematic review

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