Poop pills show promise for gut disease
NCT ID NCT05998213
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether fecal transplants from healthy donors could help people with ulcerative colitis, a chronic condition causing inflammation in the colon. 85 participants received either donor or their own stool via tubes and enemas. The goal was to see if donor transplants could reduce symptoms and heal the gut lining, offering a new way to manage this disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
85 people
The number who actually took part.
- Started
-
Jun 2020
- Finished
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Dec 2025
- Lead sponsor
-
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
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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: * Age ≥18 and \<70 * Ability to give informed consent * Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria * Partial mayo score of ≥ 3 and calprotectin \> 250 * Full Mayo score 5-9 * Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy * Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks. * Stable dose of budesonide in preceding 2 weeks. * Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4. * Women need to use reliable contraceptives during participation in the study * Alkaline phosphatase \> 1.5 x ULN in the subgroup of PSC/UC patients. Exclusion Criteria: * Condition leading to profound immunosuppression * For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies * Use of systemic chemotherapy * Child-Pugh B liver cirrhosis * Anti-TNFα treatment in preceding 2 months * Vedolizumab treatment in preceding 2 months * Tofacitinib treatment in preceding 2 months * Ustekinumab treatment in preceding 2 months * Cyclosporine treatment in preceding 4 weeks * Use of Methotrexate in preceding 2 months * Prednisolone dose \> 15 mg/day in preceding 2 weeks * Use of topical therapy in preceding 2 weeks * Life expectancy \< 12 months * Difficulty with swallowing * Use of systemic antibiotics in preceding 4 weeks * Use of probiotic treatment in preceding 4 weeks * Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli) * Positive C. Difficile stool test * Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica, Giardia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically many or very many blastocysts are seen. * Positive serological test for HIV * History of surgery: * presence of a pouch * presence of stoma * Known intra-abdominal fistula * Pregnancy or women who give breastfeeding * Vasopressive medication, icu stay * Signs of ileus, diminished passage * Allergy to macrogol or substituents, eg peanuts, shellfish * Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver * Crohn's disease * Subject who has any conditions that in the opinion of the investigator, would compromise the safety of the subject or the quality of the data and is an unsuitable candidate for the 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.
Contacts and locations
Locations
-
Amsterdam University Medical Center
Amsterdam, North Holland, 1061BK, Netherlands
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Other studies related to the condition(s) this trial covers.
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