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NCT06427863
Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation in Adults: a Multi-center, Randomized, Placebo-controlled Clinical Study
NA trial testing Ornidazole in Chronic Constipation in 96 participants. Not yet recruiting.
31 December 2029
Quick facts
| Lead sponsor | Faming Zhang |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 1 June 2024 |
| Primary completion | 31 December 2029 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Ornidazole (ORNIDAZOLE) — full drug profile →
- Placebo
Conditions studied
- Chronic Constipation — all drugs for Chronic Constipation →
Sponsor
Faming Zhang
Who can join
18 and older, any sex, with Chronic Constipation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Response rate of complete spontaneous bowel movements（CSBM）
Time frame: One-week, Four-week and Eight-week post-WMT
Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking r -
The extent of change observed in Constipation assessment scale (CAS) of participants
Time frame: One-week, Four-week and Eight-week post-WMT
The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe -
The extent of change observed in Patient-Assessment of Constipation Quality Of Life（PAC-QOL）of participants
Time frame: One-week, Four-week and Eight-week post-WMT
The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks.
Sponsor's own description
This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of chronic constipation in adults: a multi-center, randomized, placebo-controlled clinical study
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06427863
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Constipation
Currently open trials in the same condition.
- NCT07387952 — The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of F · NA · recruiting
- NCT06911749 — MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders · NA · recruiting
- NCT06847919 — Exploring the Potential Benefits of Probiotic Yogurt · NA · recruiting
- NCT06543979 — Anorectal Manometery in Pediatric Chronic Refractory Constipation · Phase 1, PHASE2 · recruiting
- NCT03819062 — Sacral Neuromodulation as Treatment for Chronic Constipation · NA · recruiting
Other Faming Zhang trials
Trials by the same sponsor.
- NCT04169152 — CAES for Internal Hemorrhoids and Rectal Prolapse · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06427863 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Faming Zhang
- Last refreshed: 20 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06427863.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing