Functional Gastrointestinal DisordersPhase 3FGIDsNCT05753774
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
A Phase 3 study testing FMT and Conventional drugs in people with Functional Gastrointestinal Disorders, run by Biao Zou at 1 site in China.
Trial summary
Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- FMT and Conventional drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2023to 9 Mar 2026
- Phase
- Phase 3
- 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children
Who cannot join
- organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.)
- other chronic disease
- growth failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children
Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders
Read the detailed description
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. Fecal microbiota transplantation (FMT) is a process in which a presumed healthy and diverse microbiome is transplanted to a patient using a nasogastric tube, colonoscopy, or enema, or Fecal capsule to remodel the intestinal flora balance. At present, there are few clinical studies on the treatment of FGID in children with FMT. The investigators prospectively enrolled functional children who met the Rome IV standard, and divided them into conventional treatment group or FMT group with open choice. The efficacy of the two groups was collected and compared at different time points, and the flora of children in the FMT group before and after treatment was collected to monitor FMT-related adverse reactions
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- FMT, Conventional drugs
- Keywords
- Functional Gastrointestinal Disorders;, FMT;, Safety; efficacy, efficacy
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTBiological
Also called fecal microbiota transplantation
FMT is a technique in which intestinal microbiota are transferred from a healthy screened donor to a patient, with the goal being to introduce or restore a stable microbial community in the gut. FMT was given 1-3courses, 3-6 times per courses
Conventional drugsDrug
Also called cyproheptadine
Conventional drugs include probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules
| Study group | Role | What they receive |
|---|---|---|
| fecal microbiota transplantation | Active comparator | Fecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules Receives: Biological: FMT |
| Conventional drug intervention | Sham comparator | Conventional drugs include: probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules. Receives: Drug: Conventional drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite response
Requiring a ≥50% reduction in GSRS score AND a ≥50% reduction in either the F-VAS or FPS-R score, with no addition of any non-permitted medications, was considered treatment success.
For the GSRS, a clinician-administered semi-structured interview evaluating five domains (reflux, abdominal pain, diarrhea, constipation, and dyspepsia; total score range: 15-105) was conducted. The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom.
For Faces Visual Analog Scale, patients rated their pain on an age-adapted 100-mm linear scale with cartoon facial gradients ("happy→neutral→distressed") for real-time pain intensity quantification (range: 0-100).
For revised Wong-Baker Faces Pain Scale, a six-level behaviorally anchored scale (0-10) combined with vital sign monitoring (heart rate/blood pressure correlations) was used as a visual pain assessment tool.
Measured: at weeks 4 and 8
Secondary outcomes (6)
Change in Pittsburgh sleep quality index (PSQI)
PSQI assesses sleep quality in children. A higher score indicates poorer sleep quality. The PSQI will be assessed from baseline to 1 weeks and from baseline to 1 month. PSQI is scored from 0 to 21 points. The higher the score, the worse the sleep. PSQI≥8 was poor sleep quality, and 7 was the cut-off value
Measured: 4 weeks and 8 weeks
Mean number of bowel movements per week
change in the mean number of bowel movements per week
Measured: 4 weeks and 8weeks
Bristol stool scale
Change in stool consistency assessed using the Bristol Stool Form Scale. The Bristol stool classification divides stool into seven categories. Types 1 and 2 indicate constipation; Types 3 and 4 are ideal for bowel movements, while types 5 to 7 indicate possible diarrhea.
Measured: 4 weeks and 8 weeks
Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)
IBS-SSS is a visual assessment scale (VAS) rating from 0 to 100, with total scores ranging from 0 to 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.
Measured: 4 weeks and 8 weeks
gut microbial
Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.
Measured: 4 weeks and/or 8 weeks
Adverse events
All possible adverse events after FMT: fever, abdominal pain, infectious diseases and others
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start3 Apr 2023
- Primary completion5 Jan 2026
- Study completion9 Mar 2026
Why it stopped: The study was terminated early because recruitment of eligible children with refractory functional abdominal pain disorders was slower than anticipated, and enrollment of the planned 50 participants was not feasible within the approved study period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biao Zou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Biao Zou, Tongji Hospital
- Investigators
- Zhihua Huang, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753774
- Sponsor's protocol ID
- 027-63639582
- Acronym
- FGIDs
- Status last verified
- May 2026
- First submitted
- 11 Feb 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children
- ClinicalTrials.gov ID
- NCT05753774
- Acronym / sponsor ID
- FGIDs / 027-63639582
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- Functional Gastrointestinal Disorders;, FMT;, Safety; efficacy, efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early because recruitment of eligible children with refractory functional abdominal pain disorders was slower than anticipated, and enrollment of the planned 50 participants was not feasible within the approved study period.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Biao ZouUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 3 Mar 2023 (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.
Safety and efficacy of FMT in Pediatric Functional Gastrointestinal Disorders
Detailed description
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. Fecal microbiota transplantation (FMT) is a process in which a presumed healthy and diverse microbiome is transplanted to a patient using a nasogastric tube, colonoscopy, or enema, or Fecal capsule to remodel the intestinal flora balance. At present, there are few clinical studies on the treatment of FGID in children with FMT. The investigators prospectively enrolled functional children who met the Rome IV standard, and divided them into conventional treatment group or FMT group with open choice. The efficacy of the two groups was collected and compared at different time points, and the flora of children in the FMT group before and after treatment was collected to monitor FMT-related adverse reactions
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| fecal microbiota transplantation | Active comparator | Biological: FMTFecal microbiota transplantation routes include the upper digestive tract, lower digestive tract, or oral fecal microbiota transplantation capsules |
| Conventional drug intervention | Sham comparator | Drug: Conventional drugsConventional drugs include: probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children
Key exclusion criteria (3 listed)
- organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.)
- other chronic disease
- growth failure
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 |
|---|---|---|
| FMTAlso: fecal microbiota transplantationFMT is a technique in which intestinal microbiota are transferred from a healthy screened donor to a patient, with the goal being to introduce or restore a stable microbial community in the gut. FMT was given 1-3courses, 3-6 times per courses | Biological | fecal microbiota transplantation |
| Conventional drugsAlso: cyproheptadineConventional drugs include probiotics and omeprazole, and cyproheptadine and L-Glutamine and Sodium Gualenate Granules | Drug | Conventional drug intervention |
Primary outcome
The composite response
Time frame: at weeks 4 and 8
Requiring a ≥50% reduction in GSRS score AND a ≥50% reduction in either the F-VAS or FPS-R score, with no addition of any non-permitted medications, was considered treatment success. For the GSRS, a clinician-administered semi-structured interview evaluating five domains (reflux, abdominal pain, diarrhea, constipation, and dyspepsia; total score range: 15-105) was conducted. The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. For Faces Visual Analog Scale, patients rated their pain on an age-adapted 100-mm linear scale with cartoon facial gradients ("happy→neutral→distressed") for real-time pain intensity quantification (range: 0-100). For revised Wong-Baker Faces Pain Scale, a six-level behaviorally anchored scale (0-10) combined with vital sign monitoring (heart rate/blood pressure correlations) was used as a visual pain assessment tool.
6 secondary outcomes
Change in Pittsburgh sleep quality index (PSQI)
Time frame: 4 weeks and 8 weeks
Mean number of bowel movements per week
Time frame: 4 weeks and 8weeks
Bristol stool scale
Time frame: 4 weeks and 8 weeks
Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)
Time frame: 4 weeks and 8 weeks
gut microbial
Time frame: 4 weeks and/or 8 weeks
Adverse events
Time frame: 4 weeks and 8 weeks
Results and safety
The study was stopped early (reason given: The study was terminated early because recruitment of eligible children with refractory functional abdominal pain disorders was slower than anticipated, and enrollment of the planned 50 participants was not feasible within the approved study period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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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.
Zhihua Huang study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FMT and Conventional drugs in people with Functional Gastrointestinal Disorders, run by Biao Zou at 1 site in China.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early because recruitment of eligible children with refractory functional abdominal pain disorders was slower than anticipated, and enrollment of the planned 50 participants was not feasible within the approved study period.). Results are not available in the source record.
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?
The composite response (time frame: at weeks 4 and 8). 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 3 Aug 2026.