Probiotic for Colic
(PIXAR Trial)
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.12345Why 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.13467
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single strain probiotic or placebo in sachet form for the treatment of infant colic
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Probiotic
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Archer-Daniels-Midland Company
Lead Sponsor
Vedic Lifesciences Pvt. Ltd.
Industry Sponsor
Atlantia Food Clinical Trials
Industry Sponsor