Study on the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Functional Gastrointestinal Disorders
NCT07925424, Not applicable, Not yet recruiting, Zhongshan Hospital Xiamen University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study on the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Functional Gastrointestinal Disorders | ClinicalTrials.gov |
| NCT number | NCT07925424 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Zhongshan Hospital Xiamen University | ClinicalTrials.gov |
| Conditions | Functional Gastrointestinal Disorders | ClinicalTrials.gov |
| Interventions | Fecal microbiota transplantation (oral capsule), Fecal microbiota transplantation (nasojejunal tube), Fecal microbiota transplantation (colonoscopic catheter), Conventional symptomatic medications | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Clinical response rate at week 12 | 12 weeks after enrollment | The proportion of participants achieving clinical response (≥50% reduction in symptom score). Compare treatment responses across FGID subtypes (IBS-C, IBS-D, mixed IBS, functional constipation, functional diarrhea, functional bloating), and compare efficacy among three FMT administration routes. | ClinicalTrials.gov |
| Secondary | Adverse events of FMT | From FMT initiation to week 12 | The type, frequency and severity of adverse events during transplantation, within 4 weeks (short-term) and within 12 weeks (long-term) after transplantation; compare route-related safety risks. | ClinicalTrials.gov |
| Secondary | Change in quality of life assessed by the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire | Baseline, week 12 | The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire, ranging from 0 to 100. Higher scores indicate worse quality of life. Assessments will be performed at baseline and week 12. | ClinicalTrials.gov |
| Secondary | Change in gut microbial alpha-diversity | Baseline, week 12 | Gut microbial alpha-diversity (e.g., Shannon index, Chao1 index). Fecal samples will be collected for 16S rRNA sequencing. | ClinicalTrials.gov |
| Secondary | Change in quality of life assessed by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire | Baseline, week 12 | The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, ranging from 0 to 112. Higher scores indicate worse quality of life. Assessments will be performed at baseline and week 12. | ClinicalTrials.gov |
| Secondary | Change in gut microbial beta-diversity | Baseline, week 12 | Gut microbial beta-diversity, reflecting overall dissimilarity of microbial community composition. Fecal samples will be collected for 16S rRNA sequencing. | ClinicalTrials.gov |
| Secondary | Changes in relative abundance of beneficial taxa and microbiota engraftment | Baseline, week 12 | Relative abundance of beneficial bacterial taxa and the degree of microbiota engraftment toward donor microbial profiles. Fecal samples will be collected for 16S rRNA sequencing. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)