Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02828410 · ClinicalTrials.gov registry record · NA
Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA
A NA study of Pouchitis and Irritable Pouch Syndrome, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT02828410 is a NA study of Pouchitis and Irritable Pouch Syndrome that has completed, run by Boston Medical Center. The registered enrollment target is 6 participants, below the 26-participant average among 5 other Pouchitis trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02828410, a NA study of Pouchitis and Irritable Pouch Syndrome, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label trial to test the hypothesize that serum bovine immunoglobulin protein isolate (SBI) will improve the nutritional status and quality of life (QOL) of patients with an ileal pouch anal anastomosis (IPAA) and symptoms of pouchitis. Subjects with symptomatic IPAA will receive two packets of EnteraGam twice daily (total daily dose of 20 g SBI) for up to 24 weeks. The primary objective of this study is to determine whether SBI therapy leads to improved nutritional status and QOL. A secondary objective is to evaluate SBI in the management of their disease, including impact on clinical symptoms.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT SBI
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-07 |
| Est. Completion | 2018-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02828410
The ClinicalTrials.gov registry entry for NCT02828410 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26-participant average among 5 other Pouchitis trials with a reported enrollment target (77% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pouchitis appearing as the primary indexed condition, and to 1 intervention - of which SBI is the first listed.
NCT02828410 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02828410 about?
NCT02828410 is a clinical study titled "Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA". This is an open label trial to test the hypothesize that serum bovine immunoglobulin protein isolate (SBI) will improve the nutritional status and quality of life (QOL) of patients with an ileal pouch anal anastomosis (IPAA) and symptoms of pouchitis. Subjects with symptomatic IPAA will receive two ...
What is the current status of trial NCT02828410?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2016-07. Estimated completion is 2018-06.
What conditions does trial NCT02828410 study?
This clinical trial studies the following conditions: Pouchitis, Irritable Pouch Syndrome.
What interventions are being tested in trial NCT02828410?
The interventions under investigation include: SBI (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02828410?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02828410 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pouchitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis
COMPLETED · NA
-
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
RECRUITING · Phase 4
-
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
RECRUITING · Early Phase 1
-
CLF065 for Chronic Pouchitis
RECRUITING · Phase 2
-
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
RECRUITING · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.