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NCT04309019
Constipation, Gut Microbiome, and Microbial-derived Uremic Toxins From the Gut Microbiota in HD Patients
trial in Constipation in 61 participants. Completed in 31 December 2020.
31 December 2020
Quick facts
| Lead sponsor | Tungs' Taichung Metroharbour Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 61 |
| Start date | 10 March 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Taiwan |
Conditions studied
- Constipation — all drugs for Constipation →
- Inflammation — all drugs for Inflammation →
Sponsor
Tungs' Taichung Metroharbour Hospital
Who can join
Adults 20 to 90, any sex, with Constipation or Inflammation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic constipation is a prevalent, multifactorial gastrointestinal disorder, and its etiology and pathophysiology remain poorly understood. Recently studies using 16S rDNA-based microbiota profiling have demonstrated dysbiosis of gut microbiota in chronic constipation. In addition, alterations of fecal flora of the a group of severely constipated patients had been reported. Constipation, an indicator of gut dysbiosis in dialysis patients, may also pose a greater burden in dialysis patients. Some recent findings highlight the plausible link between the gut and the kidneys and provide additional insights into the pathogenesis of kidney disease progression and development of cardiovascular disease. Yet, the constipation in dialysis patients is usually ignored and not even draw the attention of dialysis physician as an ominous risk factor of constipated dialysis patients. In view of multiple factors link the gut and cardiorenal pathophysiology, and the scarcity of literature on this issue, the aim of this study is want to know if constipation can result in any changes to the intestinal microbiota and is it associated with inflammation, atherogenic profile and levels of microbial derived uremic toxins. Here, the investigators use both self-reported Bristol stool form scale (BSFS) scores and Roman IV criteria to diagnose constipation and 16S rDNA Illumina amplicon profiles of faecal samples of 90 dialysis patients to assess potential associations between microbiota composition and constipation. The relationship between uremic toxins and inflammation will also be explored in the dialysis suffering from constipation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04309019
- Europe PMC full search
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Related trials
Other recruiting trials for Constipation
Currently open trials in the same condition.
- NCT07462481 — Probiotic Improve Constipation · NA · recruiting
- NCT07466914 — Constipation in Children With Cerebral Palsy · active not recruiting
- NCT07215351 — Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women · NA · recruiting
- NCT07135362 — The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement · NA · recruiting
- NCT07091084 — A Study of Herbal Supplements in Cancer Survivors With Constipation · NA · recruiting
Other Tungs' Taichung Metroharbour Hospital trials
Trials by the same sponsor.
- NCT07443280 — Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic · NA · not yet recruiting
- NCT07461233 — Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemo · NA · not yet recruiting
- NCT06877585 — Association Between Fecal Microbiota Composition, Metabolite Concentrations, and Indoxyl Sulfate Levels · recruiting
- NCT06211244 — Association of Serum Eotaxin Levels and Markers of Myocardiac Injury in Hemodialysis Patients · completed
- NCT06206694 — Serum YKL-40 Levels is Associated With Nutritional and Oxidative Status of Hemodialysis Patients · completed
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 NCT04309019 (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 Tungs' Taichung Metroharbour Hospital
- Last refreshed: 29 April 2022
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/NCT04309019.
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