Infantile ColicPIXARNCT05432479
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
A study testing Probiotic in people with Infantile Colic, run by The Archer-Daniels-Midland Company at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Sep 2022to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Atlantia Food Clinical Trials
Chicago, Illinois, 60611
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
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.
- Conditions
- Infantile Colic
- Being tested
- Probiotic, Placebo
- Keywords
- probiotic, Bifidobacterium, colic, cry
- Medical subject headings
- Colic, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
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
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Arm receiving investigation product (probiotic) Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Arm receiving placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cry and fuss time
eDiary parent reported cry and fuss time
Measured: Day 0, Day 28
Secondary outcomes (5)
Change in cry and fuss time
eDiary parent reported cry and fuss time
Measured: Day 0, Day 7
Resolution of colic symptoms
Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
Measured: Day 0, Day 28
Change in cry and fuss time bouts
eDiary parent reported cry and fuss bouts
Measured: Day 0, Day 7, Day 28
Change in sleeping time
eDiary parent reported sleep time
Measured: 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
Measured: Day 0, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start30 Sep 2022
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Vedic Lifesciences Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432479
- Sponsor's protocol ID
- PCTB202010
- Acronym
- PIXAR
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
- ClinicalTrials.gov ID
- NCT05432479
- Acronym / sponsor ID
- PIXAR / PCTB202010
- Conditions
- Infantile Colic
- Keywords
- probiotic, Bifidobacterium, colic, cry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Vedic Lifesciences Pvt. Ltd.
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: ProbioticArm receiving investigation product (probiotic) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboArm receiving placebo |
Who may qualify
- Ages
- 3 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticSingle 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 | Dietary supplement | Active |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Change in cry and fuss time
Time frame: Day 0, Day 28
eDiary parent reported cry and fuss time
5 secondary outcomes
Change in cry and fuss time
Time frame: Day 0, Day 7
Resolution of colic symptoms
Time frame: Day 0, Day 28
Change in cry and fuss time bouts
Time frame: Day 0, Day 7, Day 28
Change in sleeping time
Time frame: Day 0, Day 7, Day 28
Change in the use of rescue medications
Time frame: Day 0, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Infantile Colic, run by The Archer-Daniels-Midland Company at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cry and fuss time (time frame: Day 0, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.