Trial · NCT07896083
Study on the Effects of Probiotic on Infant Gut Microbiota and Immune Regulation
NCT07896083, Not applicable, Recruiting, BYHEALTH Co., LTD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study on the Effects of Probiotic on Infant Gut Microbiota and Immune Regulation. Trials, record NCT07896083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07896083
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study on the Effects of Probiotic on Infant Gut Microbiota and Immune Regulation
- NCT number
- NCT07896083
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 370 participants, estimated
- Lead sponsor
- BYHEALTH Co., LTD
- Conditions
- Healthy Infants
- Interventions
- Probiotic, Maltodextrin
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fecal Secretory Immunoglobulin A (sIgA) Concentration | Baseline (Week 0), Week 12, Week 24. | Fecal sIgA concentration measured in feces samples at each assessment time point using Enzyme-linked Immunosorbent Assay (ELISA). Results will be reported as absolute concentrations in μg/g. |
| Primary | Body Weight | Baseline (Week 0), Week 12, Week 24. | Body weight measured at each assessment time point and reported as an absolute value in kg. |
| Primary | Body Length | Baseline (Week 0), Week 12, Week 24. | Body length measured at each assessment time point and reported as an absolute value in cm. |
| Primary | Head Circumference | Baseline (Week 0), Week 12, Week 24. | Head circumference measured at each assessment time point and reported as an absolute value in cm. |
| Primary | Gut microbiota composition | Baseline (Week 0), Week 12, Week 24. | Relative abundance of fecal microbial taxa determined by 16S rRNA (rRNA) gene sequencing and reported as a percentage of sequencing reads at each assessment time point, especially the relative abundances of Lactobacillus and Bifidobacterium. |
| Secondary | Stool Amount | Baseline (Week 0), Week 12, Week 24. | Stool amount assessed based on the proportion of the diaper surface area covered by stool for each recorded bowel movement. Stool amount will be categorized into three levels: less than 25% of the diaper surface area covered by stool, 25%-50% covered, and more than 50% covered. The percentage of stool records in each category will be summarized for each assessment period. |
| Secondary | Occurrence of Abdominal Bloating | Baseline (Week 0), Week 12, Week 24. | Incidence of abdominal bloating, assessed by a caregiver-reported symptom diary/questionnaire. |
| Secondary | Occurrence of Diarrhea | Baseline (Week 0), Week 12, Week 24. | Incidence of diarrhea, assessed by a caregiver-reported symptom diary/questionnaire. |
| Secondary | Occurrence of Abdominal Pain | Baseline (Week 0), Week 12, Week 24. | Incidence of abdominal pain, assessed by a caregiver-reported symptom diary/questionnaire. |
| Secondary | Fecal Short-Chain Fatty Acid (SCFA) Concentration | Baseline (Week 0), Week 12, Week 24. | Total fecal SCFA concentration calculated as the sum of the concentrations of the prespecified individual SCFAs measured in fecal samples. Results will be reported as absolute concentrations in μmol/g at each assessment time point. |
Source ClinicalTrials.gov
Outcomes0
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/NCT07896083
GET https://conductscience.org/api/trials/v1/NCT07896083/registered