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

Trial Summary

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.

What data supports the effectiveness of this treatment for colic?

Research shows that probiotics, particularly Lactobacillus reuteri, can help reduce colic symptoms in breastfed babies by decreasing crying time and improving gut health. ^{1 2 3 4 5}

Is the probiotic treatment for colic safe for humans?

Research on probiotics, including Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG, suggests they are generally safe for infants with colic, as studies have focused on their safety and effectiveness in this group. ^{3 6 7 8 9}

How does the probiotic treatment for colic differ from other treatments?

Probiotics are unique because they involve live microorganisms that can provide health benefits by altering the gut flora, which is different from traditional medications that might target symptoms directly. This approach is novel for colic, as it focuses on balancing the gut bacteria, which may help reduce symptoms associated with digestive disturbances. ^{2 10 11 12 13}

What is the purpose of this trial?

This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Microbiota in Functional Gastrointestinal Disorders in Infancy: Implications for Management. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Using murine colitis models to analyze probiotics-host interactions. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Probiotics for the Treatment of Infantile Colic: A Systematic Review. [2022]

4. Scotland pubmed.ncbi.nlm.nih.gov

Evidence of Lactobacillus reuteri to reduce colic in breastfed babies: Systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Probiotics for infantile colic: a systematic review. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Probiotics in the treatment of infantile colic: a meta-analysis of randomized controlled trials. [2022]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Hypoallergenic formula with Lactobacillus rhamnosus GG for babies with colic: A pilot study of recruitment, retention, and fecal biomarkers. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 2: Probiotics and crying time in babies with infantile colic. [2015]

10. Australia pubmed.ncbi.nlm.nih.gov

Probiotics in infective diarrhoea and inflammatory bowel diseases. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Probiotics in gastroenterology: indications and future perspectives. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Probiotics in the management of colonic disorders. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Probiotics and gastrointestinal diseases. [2022]