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COMPLETED NA

Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA

NCT02828410 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DIETARY_SUPPLEMENT SBI

Study Locations (1)

Massachusetts

  • Boston Medical Center — Boston

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2016-07
Est. Completion 2018-06
Phase NA

Sponsor

Boston Medical Center

192 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 192 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02828410 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02828410?

The interventions under investigation include: SBI (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02828410?

This trial is sponsored by Boston Medical Center, which has 192 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial