Could a 'Poop Pill' ease diabetic stomach pain?
NCT ID NCT06340217
First seen Jun 26, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study tests whether transferring gut bacteria from healthy donors (called washed microbiota transplantation) can help people with diabetic gastroparesis—a condition where the stomach empties too slowly, causing bloating, nausea, and fullness. Researchers will give 46 adults either the bacteria or a placebo and track symptom changes over time. The goal is to see if this approach safely reduces symptoms by at least half.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- washed microbiota transplantation (WMT) from healthy donors
- What this could lead to
- If it works, this could offer a new way to relieve bloating, nausea, and fullness in people with diabetic gastroparesis.
- What could go wrong
- This is a small, early-stage trial with only 46 participants. The placebo group may also improve, and long-term benefits or risks are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to enter the study: 1. Diagnosed with diabetes for over 1 year; 2. Accompanied by symptoms such as abdominal bloating, early satiety, persisting for at least 3 months, with a GCSI Total Score greater than/equal to 2.3; 3. Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound; 4. Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months; 5. Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form; 6. The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study. Exclusion Criteria: Subjects meeting any of the following exclusion criteria must be excluded from the study: Subjects who: 1. Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial; 2. Have a prior history of gastric surgery, including but not limited to gastric bypass, gastrectomy, gastric banding, pyloroplasty, fundoplication, or vagotomy in past 1 year; 3. Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes; 4. Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists; 5. Have contraindications for intestinal tubing; 6. Have a history of medication that regulate intestinal microbiome in last 48 hours; 7. Have serious diabetic complications need immediately be dealt, such as diabetic ketoacidosis 8. Have poor lung function and those deemed by the investigator to be affected by the study treatment, such as during COPD exacerbations; 9. Have any of the following abnormalities in cardiac function and cardiac performance: * Cardiac function rating≥Ⅲ according to New York Heart Association (NYHA); * New myocardial infarction or unstable angina pectoris within 6 months; * Electrocardiogram indicated prolonged QTc interval (male QTc≥450ms, female QTc≥470ms); * requiring drug intervention (more than Ⅱ atrioventricular block). 10. Have preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points); 11. Kidney disease with KDIGO stage 3b (GFR\<45 ml/min/1.73m2) or above; 12. Have infectious diseases such as active hepatitis (requiring long-term use of drugs), HIV or active tuberculosis; 13. Have a history of drug abuse, alcoholism (defined as consuming more than 14 units per week, with 1 unit equivalent to 360 mL of beer, 45 mL of 40% alcohol, or 150 mL of wine), or substance misuse; 14. Other significant systemic illnesses, such as malignant tumors; 15. Have other situations in which the investigator deems it inappropriate to participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
RECRUITINGNanjing, Jiangsu, China
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