An interventional study of Probiotic and Placebo in Infantile Colic, sponsored by The Archer-Daniels-Midland Company. Completed at 2 sites in 2 countries. Open to participants aged 3 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by The Archer-Daniels-Midland Company · Not applicable, Interventional, and Treatment
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.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 101 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →The Archer-Daniels-Midland Company is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm receiving investigation product (probiotic)
Dietary Supplement: Probiotic
Arm receiving placebo
Dietary Supplement: Placebo
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
Change in cry and fuss time
eDiary parent reported cry and fuss time
Time frame: Day 0, Day 28
Change in cry and fuss time
eDiary parent reported cry and fuss time
Time frame: Day 0, Day 7
Resolution of colic symptoms
Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
Time frame: Day 0, Day 28
Change in cry and fuss time bouts
eDiary parent reported cry and fuss bouts
Time frame: Day 0, Day 7, Day 28
Change in sleeping time
eDiary parent reported sleep time
Time frame: Day 0, Day 7, Day 28
Change in the use of rescue medications
Change in the proportion of participants needing to use rescue medications between the study arms
Time frame: Day 0, Day 28
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)
Time frame: Day 0, Day 28
Change in maternal quality of life and mental health
Change in maternal QoL using MAPP/QoL (improvement marked by increase in the total score)
Time frame: Day 0, Day 28
Resolution of colic symptoms
Reduction of cry and fuss time (parent reported) greater than 50% comparing to baseline
Time frame: Day 0, Day 28
Change in the use of rescue medication drops
Change in the number of rescue medication drops used between the study arms
Time frame: Day 0, Day 7, Day 28
Change in duration of daily crying and fussing episodes
Change in mean duration per crying and fussing episode per day
Time frame: Day 0, Day 7, Day 28
Changes in gut microbiome composition
Changes in microbiome composition as measured by changes in alpha and beta diversity of the gut microbiome throughout the study as compared to placebo and baseline
Time frame: Day 0, Day 28
Change in fecal calprotectin concentration
Changes in fecal calprotectin concentration throughout the study as compared to placebo and baseline
Time frame: Day 0, Day 28
Adverse Events (AEs)
Reports of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From enrolment to Day 35
Change in vital signs
Changes in vital sign measurements (heart rate \[bpm\] and body temperature \[°F\]) collected during the study will be summarised by treatment group
Time frame: Day 0, Day 28
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Apr 2026, 42 months.
Of 44 interventional studies with no phase under Colic, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 42 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion May 2026 → Apr 2026 and completion May 2026 → Apr 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
The Archer-Daniels-Midland Company