Synbiotic Supplement for Colic

Overseen By Stephen VanDien, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Persephone Biosciences

Must not be taking: Probiotics, Antibiotics, Pancreatic enzymes, others

Disqualifiers: Congenital malformations, Infections, Gastroesophageal reflux, others

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special supplement, composed of friendly gut bacteria and nutrients from human milk, can improve gut health in infants and toddlers. The focus is on healthy children who are still in diapers and have not been diagnosed with chronic health issues. Participants will receive either the synbiotic supplement (a combination of probiotics and prebiotics) or a placebo (a non-active substitute) for one month. Researchers will study changes in gut health and digestion, which could potentially help prevent tummy troubles and related immune issues in young children. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance children's health.

Will I have to stop taking my current medications?

Participants must stop taking certain medications and supplements before joining the trial. Specifically, infants and toddlers cannot have taken probiotic supplements, antibiotics, or medications affecting digestion, stool, growth, or microbiome within three months prior to enrollment.

Is there any evidence suggesting that this synbiotic supplement is safe for infants and toddlers?

Research has shown that the synbiotic supplement, which combines probiotics (helpful bacteria) and prebiotics (food for these bacteria), appears safe for infants. Studies have specifically examined probiotics like Bifidobacterium, included in this supplement, and found them to be well-tolerated by infants.

One study examined the safety of a probiotic mixture over an extended period. It included several probiotic strains similar to those in the current supplement. This study found no major negative reactions, meaning the babies did not experience any significant side effects. Another study showed that infants taking similar probiotic mixtures had fewer infections over time compared to those who did not.

Overall, these findings suggest that the synbiotic supplement is likely safe for infants and toddlers. It has been tested in similar forms without serious issues. However, as with any treatment, monitoring for any unexpected reactions is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for colic, which often include dietary changes and medications like simethicone or probiotics alone, the synbiotic supplement under investigation combines both probiotics and prebiotics. This dual-action approach is designed to not only introduce beneficial bacteria to the gut but also provide the nutrients necessary for these bacteria to thrive, potentially enhancing their effectiveness. Researchers are excited about this treatment because it may offer a more comprehensive solution by promoting a healthier gut environment, which could lead to faster and more significant relief of colic symptoms in infants.

What evidence suggests that this synbiotic supplement could be effective for colic?

This trial will compare a synbiotic supplement with a placebo to evaluate its effectiveness in reducing colic symptoms in babies. Studies have shown that synbiotic supplements, which combine probiotics (helpful bacteria) and prebiotics (food for these bacteria), may help reduce colic symptoms. In one study, babies with colic who took a synbiotic supplement cried 2.7 hours less, while those who took a placebo cried 1.2 hours less. Another study found that probiotics significantly reduced crying time and improved parental satisfaction. However, not all research agrees, as some studies did not find significant improvement in colic symptoms with synbiotics. Overall, early research suggests possible benefits, but results can vary. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for infants and toddlers aged 2-24 months who suffer from colic. Initially, only those aged 12-24 months will be included until a safety review allows younger participants. Infants with certain health conditions or dietary restrictions may not qualify.

Inclusion Criteria

- Legal Guardian of the Infant

The PI considers the Caregiver likely to adequately comply with the study protocol requirements based on demonstrated compliance with initial questionnaires and agreement to complete all diaries

- Reads, writes, and speaks English

Exclusion Criteria

My microbiome is being considered for this study.

My child has HIV, hepatitis, or is lactose sensitive.

- Exposure to COVID-19

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Online questionnaire

Treatment

Participants receive daily synbiotic supplementation or placebo for 1 month

4 weeks

Home-based sample collection at start, 1 week, and 4 weeks

Washout

Participants undergo a 2-week washout period with no supplementation

2 weeks

Home-based sample collection at 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Journals and questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Synbiotic Supplement

Trial Overview

The study tests if a synbiotic supplement (a mix of Bifidobacterium and human milk oligosaccharides) can positively change the gut microbiome compared to a lactose placebo over one month. Participants are randomly assigned to either the synbiotic or placebo group.

How Is the Trial Designed?

Group I: Synbiotic Supplement Active Control 1 Intervention

Participants aged 2 months to 24 months will receive daily synbiotic supplementation (probiotic+ prebiotic) for 1 month

Group II: Lactose Placebo Group 1 Intervention

Participants aged 2 months to 24 months will receive daily placebo (lactose) for 1 month

Who Is Running the Clinical Trial?

Persephone Biosciences

Lead Sponsor

Trials

6

Recruited

6,100+

Published Research Related to This Trial

In a study of 87 infants with colic, a multi-strain synbiotic significantly reduced crying days and evening crying duration compared to simethicone, with responder rates of 72% and 85% respectively, indicating its potential efficacy in treating infantile colic.

Both treatments were safe, with no adverse effects reported, suggesting that the multi-strain synbiotic could be a promising option for further research in managing colicky infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Piątek, J., Bernatek, M., Krauss, H., et al.[2021]

In a pilot study involving 184 infants, daily supplementation with Lactobacillus rhamnosus GG (LGG) did not significantly reduce the incidence of colic compared to a control group, with colic rates of 9.8% in the LGG group versus 5.4% in the control group.

The study found no significant differences in colic diagnosis rates by either parent-reported symptoms or physician diagnosis, indicating that LGG supplementation is not effective in preventing colic in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Analysis of Early Lactobacillus rhamnosus GG for Infant Colic Prevention. Cabana, MD., McKean, M., Beck, AL., et al.[2022]

In a study involving 150 colicky infants over 28 days, the probiotic Bifidobacterium breve CECT7263 significantly reduced daily crying time more effectively than simethicone, showing results as early as the first week.

B. breve CECT7263 not only decreased crying but also improved sleep quality for infants and enhanced parental mood, demonstrating its safety and efficacy as a treatment for infantile colic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial. Maldonado-Lobón, JA., Blanco-Rojo, R., Maldonado, J., et al.[2021]

The lactose-reduced synbiotic formula significantly decreased crying time in infants with colic by an average of 2.7 hours compared to only 1.2 hours in the control group, indicating its efficacy in managing colic symptoms.

Parents reported a significant improvement in quality of life (QoL) for both themselves and their infants when using the intervention formula, with greater improvements noted compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Dietary Intervention Answers to Baby Colic. Xinias, I., Analitis, A., Mavroudi, A., et al.[2020]

In a clinical trial involving 50 breastfed infants with colic, a synbiotic treatment significantly reduced crying time, with 82.6% of infants showing improvement at day 7 compared to 35.7% in the placebo group.

By day 30, the synbiotic group maintained a higher treatment success rate of 87% versus 46% for placebo, and no complications were reported from the synbiotic use, indicating it is a safe and effective option for managing infant colic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synbiotic in the management of infantile colic: a randomised controlled trial. Kianifar, H., Ahanchian, H., Grover, Z., et al.[2022]

In a study of 53 exclusively breastfed infants with colic, those treated with a probiotic-mixture experienced significantly less crying time per day compared to the placebo group, indicating its effectiveness in reducing symptoms of colic.

The probiotic-mixture was found to be safe, with no reported adverse events, and it also improved the quality of life for parents, suggesting a positive impact on both infants and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis. Baldassarre, ME., Di Mauro, A., Tafuri, S., et al.[2018]

Lactobacillus reuteri DSM17938 significantly reduces crying and fussing time in breastfed infants with colic, with an average decrease of 25.4 minutes compared to a placebo group, based on a meta-analysis of 345 infants.

The probiotic was found to be nearly twice as effective in achieving treatment success in breastfed infants, but its effectiveness in formula-fed infants remains unclear and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis. Sung, V., D'Amico, F., Cabana, MD., et al.[2022]

A systematic review of five randomized controlled trials found that the probiotic Lactobacillus reuteri significantly reduces crying and fussing time in breastfed infants with colic, with a 2.3-fold greater chance of improvement compared to controls.

Probiotic supplementation with L. reuteri was shown to be safe, with no reported adverse events, suggesting it is a viable option for managing infantile colic in breastfed infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics for the Treatment of Infantile Colic: A Systematic Review. Schreck Bird, A., Gregory, PJ., Jalloh, MA., et al.[2022]

Lactobacillus reuteri DSM 17938 significantly improved treatment effectiveness for infantile colic, reducing crying time at two and three weeks, based on a meta-analysis of six randomized controlled trials involving 423 infants.

The treatment was found to be safe, with no adverse effects on infants' growth measurements, but its benefits may diminish over time as infants naturally improve, highlighting the need for further high-quality studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of the Probiotic Bacterium Lactobacillus reuteri DSM 17938 for Infantile Colic: A Meta-Analysis of Randomized Controlled Trials. Xu, M., Wang, J., Wang, N., et al.[2022]

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