An interventional study of Fecal microbiota transplantation (oral capsule) and Fecal microbiota transplantation (nasojejunal tube) in Functional Gastrointestinal Disorders, sponsored by Zhongshan Hospital Xiamen University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Zhongshan Hospital Xiamen University · Not applicable, Interventional, and Treatment
This study is designed to explore the efficacy and safety of fecal microbiota transplantation (FMT) with different delivery routes for patients with functional gastrointestinal disorders (FGIDs). The response to FMT varies greatly, which is related to donor selection, administration route, individual patient characteristics and microbiota compatibility. This single-center, prospective randomized controlled trial plans to enroll 200 FGID patients refractory to conventional medications from OCT 2026 to OCT 2029. Eligible participants will be randomized into a conventional medication group or an FMT group; the FMT group will be further randomized into three subgroups according to transplantation routes: oral capsule, nasojejunal tube and colonoscopic administration. Clinical data, laboratory, imaging and endoscopic results will be collected. Gut microbiota and metabolites will be analyzed before and after treatment. Clinical efficacy and safety will be evaluated at week 12.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Zhongshan Hospital Xiamen University is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1: Aged 1865 years, regardless of gender;
2: Meeting the Rome IV diagnostic criteria (independently confirmed by two physicians with associate-senior title or above), including subtypes of irritable bowel syndrome: IBS-D (diarrhea-predominant), IBS-C (constipation-predominant), and IBS-M (mixed-type).
3: Patients with functional constipation (excluding defecatory disorder-related constipation), functional diarrhea, or functional bloating, who have poor response to or intolerance of at least one conventional pharmacotherapy (e.g., antispasmodics, antidiarrheals, osmotic laxatives), with a disease duration of ≥6 months.
4: Voluntarily participating in this study, signing a written form, and committing to comply with the study protocol.
Exclusion Criteria:
1: History of prior colectomy or planned surgery within 6 months
2: to colonoscopy (severe luminal stenosis, toxic megacolon, risk of perforation, etc.)
3: comorbid diagnoses: uncontrolled infectious enteritis, positive Clostridioides difficile test, intestinal ischemia, radiation colitis, active diverticular disease
4: ast or present history of active tuberculosis, active / / infection opportunistic infections
5: severe systemic diseases: decompensated liver cirrhosis, Class Ⅲ-Ⅳ heart failure, renal insufficiency (\<30 ml/min)
6: concomitant malignant tumor or lymphoma
7: severe immunodeficiency or long-term use of or systemic .
8: Pregnancy, lactation, or planned pregnancy within 6 months
9: allergy to FMT or study-related medications (laxatives, PPIs, etc.);
10: poor compliance, psychiatric disorders,or any other conditions deemed by investigators to render the subject unsuitable for participation in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fecal microbiota transplantation via oral capsule combined with conventional symptomatic treatment for functional gastrointestinal disorders.
Biological: Fecal microbiota transplantation (oral capsule)
Fecal microbiota transplantation delivered through nasojejunal tube combined with conventional symptomatic treatment for functional gastrointestinal disorders.
Biological: Fecal microbiota transplantation (nasojejunal tube)
Fecal microbiota transplantation administered by colonoscopic catheter combined with conventional symptomatic treatment for functional gastrointestinal disorders.
Biological: Fecal microbiota transplantation (colonoscopic catheter)
Routine symptomatic drug treatment for functional gastrointestinal disorders without fecal microbiota transplantation.
Drug: Conventional symptomatic medications
FMT prepared from screened donor stool, administered by oral capsules, combined with conventional symptomatic treatment.
FMT prepared from screened donor stool, infused via nasojejunal tube, combined with conventional symptomatic treatment.
FMT prepared from screened donor stool, delivered through colonoscopic catheter, combined with conventional symptomatic treatment.
Routine symptomatic drugs for functional gastrointestinal disorders, without fecal microbiota transplantation.
Clinical response rate at week 12
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.
Time frame: 12 weeks after enrollment
Adverse events of FMT
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.
Time frame: From FMT initiation to week 12
Change in quality of life assessed by the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire
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.
Time frame: Baseline, week 12
Change in gut microbial alpha-diversity
Gut microbial alpha-diversity (e.g., Shannon index, Chao1 index). Fecal samples will be collected for 16S rRNA sequencing.
Time frame: Baseline, week 12
Change in quality of life assessed by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
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.
Time frame: Baseline, week 12
Change in gut microbial beta-diversity
Gut microbial beta-diversity, reflecting overall dissimilarity of microbial community composition. Fecal samples will be collected for 16S rRNA sequencing.
Time frame: Baseline, week 12
Changes in relative abundance of beneficial taxa and microbiota engraftment
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.
Time frame: Baseline, week 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Zhongshan Hospital Xiamen University