Probiotic for Colic

(PIXAR Trial)

Overseen By ADM Medical Team

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Archer-Daniels-Midland Company

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Congenital disorders, Failure to thrive, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a probiotic can reduce colic symptoms in infants. Colic occurs when a baby cries or fusses for more than 3 hours a day, at least 3 days a week. The trial compares the effects of a probiotic (beneficial bacteria) to a placebo (a harmless pill with no active treatment). It seeks infants between 3 and 12 weeks old who cry frequently and are otherwise healthy. Families interested should ensure their baby hasn't recently taken antibiotics or probiotics. As an unphased trial, this study allows families to contribute to important research that could lead to new ways to soothe colicky babies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude infants and breastfeeding mothers who have used antibiotics or probiotics recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that probiotics are usually safe for babies. For example, one study found that baby formulas with certain probiotics, like B. lactis and S. thermophilus, were well accepted by infants, meaning the babies didn't have adverse reactions and grew normally. Another study found that adding probiotics to a baby's diet increased the healthy bacteria in their stomach, suggesting they are safe to use.

Overall, probiotics have been tested in many studies without causing serious side effects. While every baby is different, these findings suggest that probiotics can be safely used to help with issues like colic. However, it's always important to monitor for any unusual reactions when introducing something new to a baby's diet. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using probiotics for colic because, unlike traditional treatments such as dietary changes or medications to relieve symptoms, probiotics offer a natural approach by promoting a healthy balance of gut bacteria. This new method could address the root cause of colic rather than just managing its symptoms. Probiotics are generally considered safe and have fewer side effects compared to conventional medications, making them an appealing option for infants.

What evidence suggests that this probiotic is effective for treating infant colic?

This trial will compare the effects of a probiotic with a placebo in treating infant colic. Research has shown that probiotics can help treat infant colic. One study found that probiotics reduced crying time in colicky babies by about 68 minutes a day. Another study showed that the probiotic *Lactobacillus reuteri* significantly decreased crying and fussing in breastfed babies. Additionally, babies fed formulas with probiotics experienced less colic and irritability. These findings suggest that probiotics might help soothe colicky babies and reduce their discomfort. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy infants aged 3-12 weeks, with a birth weight of at least 5.5 lbs and gestational age over 37 weeks, suffering from colic (crying >3 hours/day for >3 days/week). Parents must consent and commit to the study's procedures including attending three visits.

Inclusion Criteria

My pregnancy has reached at least 37 weeks.

My birthweight was at least 5.5 pounds.

I am between 3 weeks and 12 weeks old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single strain probiotic or placebo in sachet form for the treatment of infant colic

4 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Probiotic

Trial Overview

The study tests if a single strain probiotic given in sachet form can relieve symptoms of infantile colic. Infants will be randomly assigned to receive either the probiotic or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Arm receiving investigation product (probiotic)

Group II: Placebo Placebo Group 1 Intervention

Arm receiving placebo

Who Is Running the Clinical Trial?

The Archer-Daniels-Midland Company

Lead Sponsor

Trials

17

Recruited

1,400+

Vedic Lifesciences Pvt. Ltd.

Industry Sponsor

Trials

71

Recruited

8,000+

Atlantia Food Clinical Trials

Industry Sponsor

Trials

43

Recruited

4,300+

Published Research Related to This Trial

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]

Current evidence from well-designed, double-blind controlled trials does not strongly support the use of probiotics for treating gastrointestinal infections, with the exception of some data on rotavirus infections in children.

Probiotics may have potential therapeutic roles in treating inflammatory bowel diseases, suggesting that their mechanisms of action could be beneficial in specific gastrointestinal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics in infective diarrhoea and inflammatory bowel diseases. Gionchetti, P., Rizzello, F., Venturi, A., 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6415699/

Probiotics to prevent infantile colic - PMC - PubMed Central

The low cost and easy availability of probiotics makes them a potential prophylactic solution to reduce the incidence and prevalence of infantile colic.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8650819/

Efficacy of probiotics for managing infantile colic due to ...

[39] in a study based on the meta-analysis declared that probiotics effectively reduce the crying time in colicky infants (MD=-67.72; 95% CI, -99.79 to -35.64).

3.

publications.aap.org

publications.aap.org/pediatrics/article/141/1/e20171811/37745/Lactobacillus-reuteri-to-Treat-Infant-Colic-A-Meta

Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis

The pooled data suggest that L reuteri DSM17938 effectively reduces crying and/or fussing in breastfed infants with colic. Although the results ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002916522038229

Long-term consumption of infant formulas containing live ...

The supplemented formulas were well accepted and were associated with a lower frequency of reported colic or irritability (P < 0.001) and a lower frequency of ...

5.

tp.amegroups.org

tp.amegroups.org/article/view/128126/html

The effectiveness of Lactobacillus rhamnosus GG in the ...

For breastfed infants with colic, the probiotic group was 2 to 3 times more likely than the placebo group to experience treatment success.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9650359/

Probiotics added to maternal nutrition affect ınfantile colic ...

A study found that the total bacteria and Lactobacillus spp levels of stool samples increased after the probiotic product was added to the diet of infants with ...

7.

nature.com

nature.com/articles/s41598-018-26423-3

Probiotic supplementation and associated infant gut ...

This retrospective clinical comparison suggests that probiotic exposure during infancy has limited effects on gut microbial composition yet is associated with ...