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NCT03379597
A 12-weeks Study to Evaluate the Dietary Fiber and Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of Schizophrenia or Bipolar Disorder
NA trial testing Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) in Schizophrenia in 136 participants. Completed in 30 June 2021.
31 May 2021
Quick facts
| Lead sponsor | Central South University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 136 |
| Start date | 30 November 2017 |
| Primary completion | 31 May 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) — full drug profile →
- Dietary fiber
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Bipolar Disorder — all drugs for Bipolar Disorder →
Sponsor
Central South University
Who can join
Adults 18 to 65, any sex, with Schizophrenia or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, the investigators will evaluate the efficacy, safety and related mechanism of dietary fiber and probiotics alone and in combination as a add-on treatment in improving the antipsychotic induced weight gain, the cognitive impairment, and psychotic syndrome in schizophrenia or bipolar disorder patients. The study will recruit 100 schizophrenia or bipolar disorder patients who meet the criteria of DSM-5, and then randomized to 4 groups: probiotics group(PB group) dietary fiber group(FB group) probiotics plus dietary fiber group(PF group) and control group(CT group) for a 12-weeks clinical trail. The specific aims are to compare probiotics group versus controls on: 1) clinical core symptoms; 2) cognition;3)metabolic related markers.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Probiotics Plus Dietary Fiber Supplements Attenuate Olanzapine-Induced Weight Gain in Drug-Naïve First-Episode Schizophrenia Patients: Two Randomized Clinical Trials.
Huang J, Kang D, Zhang F, Yang Y, et al · · 2022 · cited 33× · PMID 35569003 · DOI 10.1093/schbul/sbac044 -
The effects of probiotics plus dietary fiber on antipsychotic-induced weight gain: a randomized clinical trial.
Huang J, Liu C, Yang Y, Kang D, et al · · 2022 · cited 22× · PMID 35508529 · DOI 10.1038/s41398-022-01958-2 -
Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial.
Liu C, Kang D, Xiao J, Huang Y, et al · · 2021 · cited 10× · PMID 33622382 · DOI 10.1186/s13063-021-05123-w
Verify or expand the search:
- PubMed search for NCT03379597
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Central South University trials
Trials by the same sponsor.
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- NCT07045142 — Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients · Phase 3 · recruiting
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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 NCT03379597 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central South University
- Last refreshed: 19 April 2023
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