Trial · NCT07894445
The Effect of Probiotics in Infantile Colic
NCT07894445, Not applicable, Recruiting, Federico II University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Probiotics in Infantile Colic. Trials, record NCT07894445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Probiotics in Infantile Colic
- NCT number
- NCT07894445
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Federico II University
- Conditions
- Infantile Colic
- Interventions
- Probiotic: L. reuteri total 2 × 10⁸ CFU/day, Placebo: matching oil formulation without L. reuteri
- First posted
- 2026-10-26
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily total crying and fussing time at day 7 | 7 days after initiation of intervention | Total infant crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Change in daily total crying and fussing time from baseline to day 7 | At Day 0 and at day 7 of intervention | Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Change in daily total crying and fussing time from baseline to every day during 21days of treatment | During 21 days of treatment | Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Proportion of responder patients assessed using a parent-completed daily sleep diary (Baby's Day Diary) | During the first 21 days of treatment | Proportion of patients responders to the treatment, defined as the number of infants with ≥50% reduction in crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Sleeping time | During the first 21 days of treatment | Total infant sleep duration, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | PedsQL Family Impact Module | During 21 days of treatment | Changes in PedsQL Family Impact Module range 0-100 (with higher scores reflecting better functioning) from baseline to Days 7 and 21 |
| Secondary | Maternal Edinburgh Postnatal Depression Scale score | During 21 days of treatment | Changes in Maternal Edinburgh Postnatal Depression Scale score evaluation Total score range: 0 to 30 (higher score on the Edinburgh Postnatal Depression Scale (EPDS) indicates a greater severity of symptoms) from baseline to Days 7 and 21 |
| Secondary | Number of participants experiencing adverse events and serious adverse events. | From initiation of the intervention (Day 1) through Day 28.Adverse events, serious adverse events | Number of participants experiencing at least one adverse event (AE) or serious adverse event (SAE) during the study. Events will be recorded and characterized according to type, severity, seriousness, and relationship to the study intervention. |
| Secondary | Body temperature | At day 0 and 21 | body temperature (°C) |
| Secondary | Heart rate | At day 0 and 21 | heart rate (BPM) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894445
GET https://conductscience.org/api/trials/v1/NCT07894445/registered