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NCT02358694
Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS
NA trial testing Serum-Derived Bovine Immunoglobulin in Diarrhea Predominant Irritable Bowel Syndrome in 20 participants. Completed in 1 June 2015.
1 June 2015
Quick facts
| Lead sponsor | Connecticut Children's Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 20 |
| Start date | 15 June 2014 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 June 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Serum-Derived Bovine Immunoglobulin
- Placebo
Conditions studied
- Diarrhea Predominant Irritable Bowel Syndrome — all drugs for Diarrhea Predominant Irritable Bowel Syndrome →
Sponsor
Connecticut Children's Medical Center
Who can join
Adults 8 to 18, any sex, with Diarrhea Predominant Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D. Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better than the patients who receive placebo.
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 NCT02358694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02358694 (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 Connecticut Children's Medical Center
- Last refreshed: 18 February 2019
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/NCT02358694.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing