Clinical Trials Logo

Clinical Trial Summary

The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.


Clinical Trial Description

The goal of this clinical trial is to evaluate the potential beneficial effects of a probiotic formulation on the symptoms of infantile colic. Participants diagnosed with infantile colic will be recruited to participate in this randomized, double-blind, placebo controlled, two-armed parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period. The study will consist of 3 in-person visits and 4 phone calls. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06385054
Study type Interventional
Source Lallemand Health Solutions
Contact Lya Blais, M.Sc.
Phone + 1-514-283-1387
Email lblais@lallemand.com
Status Not yet recruiting
Phase Phase 2
Start date June 2024
Completion date February 2027

See also
  Status Clinical Trial Phase
Terminated NCT00954759 - The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial N/A
Completed NCT01513304 - Chiropractic Manual Therapy in Infantile Colic N/A
Recruiting NCT02695784 - Probiotics After Discharge Phase 4
Completed NCT04374955 - The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content N/A
Terminated NCT03329222 - An Infant Formula Trial on Dietary Management of Infantile Colic N/A
Not yet recruiting NCT06462651 - Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic N/A
Withdrawn NCT01887444 - Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic N/A
Completed NCT04632888 - The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy N/A
Active, not recruiting NCT06299358 - Interventional Practices and Their Effectiveness in Infants With İnfantyl Colic N/A
Completed NCT02988791 - Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC) N/A
Completed NCT02595515 - The Effect of Chiropractic Treatment of Infantile Colic N/A
Completed NCT01258153 - Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic Phase 2
Completed NCT03434249 - Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic N/A
Not yet recruiting NCT02430831 - Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old Phase 4
Not yet recruiting NCT02094092 - Role of ProTectis on Infant Colic and Its Effect on Infant Crying Time and Maternal Mental Health N/A
Terminated NCT03477669 - Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants N/A
Completed NCT04262648 - Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns N/A
Completed NCT05244291 - Effect of Therapeutic Touch at Different Times on Infantile Colic According to Watson's Theory N/A
Not yet recruiting NCT06197100 - Supportive Care Training Given to Mothers of Babies With Infants Colic N/A
Terminated NCT02138656 - CHiropractic for Infantile Colic Study N/A