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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05432479
Other study ID # PCTB202010
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2022
Est. completion date January 2023

Study information

Verified date May 2022
Source The Archer-Daniels-Midland Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date January 2023
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Weeks
Eligibility Inclusion Criteria: - Gestational age of minimum 37 weeks. - Birthweight of minimum 2500 g (5.5 lb.). - Age of greater than 3 weeks and less than 12 weeks at enrolment. - Confirmed Infantile colic defined as: parental report of crying and/or fussing =3 hours/day for =3 days/week, confirmed prior to enrolment with an infant behaviour diary recording >3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period & for duration of study). - Participant Informed Consent form signed by parent or legal guardian. - Infant is considered healthy following physical exam. - Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits Exclusion Criteria: - Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial. - Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics). - Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery). - Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract. - Failure to thrive. - Known lactose or gluten intolerance. - Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo. - Known other causes for abdominal pain (e.g., pyloric stenosis). - Participation in any other interventional clinical study. - Immuno-compromised participant or participant with other severe chronic disorder. - Use of probiotic supplements by breastfeeding mother from child's birth to enrolment. - Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial. - Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic
Single strain probiotic in a form of a sachets with a daily dose of 1.0E+9 Colony Forming Unit (CFU) per day for 4 weeks
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Archer-Daniels-Midland Company Atlantia Food Clinical Trials

Outcome

Type Measure Description Time frame Safety issue
Other Change in maternal quality of life and mental health Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score) Day 0, Day 28
Other Change in maternal quality of life and mental health Change in maternal QoL using MMPP/QoL (improvement marked by increase in the total score) Day 0, Day 28
Primary Change in cry and fuss time eDiary parent reported cry and fuss time Day 0 , Day 28
Secondary Resolution of colic symptoms Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline Day 0, Day 28
Secondary Change in cry and fuss time bouts eDiary parent reported cry and fuss bouts Day 0, Day 28
Secondary Change in sleeping time eDiary parent reported sleep time Day 0 Day 28
Secondary Change in the use of rescue medications Change in the proportion of participants needing to use rescue medications between the study arms Day 0, Day 28
See also
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