Effect of UGIR in Adults With Compromised Gut Function and Malabsorption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients

NCT03483805

Celiac Disease

COMPLETED NA

Gluten Technology and Education for Celiac Health

NCT06059716

Celiac Disease

RECRUITING NA

Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity

NCT03798249

NCGS Gluten

UNKNOWN NA

Celiac Disease Prevention With Probiotics

NCT03176095

Celiac Disease in Children

COMPLETED NA

Treatment of Screen-detected Celiac Disease

NCT01116505

Celiac Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This prospective, non-randomized, open-label study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption. Adults with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were enrolled in the study and asked to take the study product for 6 weeks. The primary measure of the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency Questionnaire (DSFQ).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome Crohn Disease Ulcerative Colitis Celiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nutrition Support Product

Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.

Group Type EXPERIMENTAL

Nutrition Support Product

Intervention Type OTHER

Nutrition support product contains macronutrients, micronutrients, glutamine, and prebiotics. Product is in powder form (41 grams per serving) and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutrition Support Product

Nutrition support product contains macronutrients, micronutrients, glutamine, and prebiotics. Product is in powder form (41 grams per serving) and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

UGIR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body mass index 19 - 40 kg/m2
* Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease

Exclusion Criteria

* Gastroenterologic surgery within 3 months before the study period
* Have a colostomy or ileostomy bag
* Malignancy within the last 5 years
* Women who are lactating, pregnant or planning pregnancy during the study period
* Taking antibiotic, antiparasitic, or antifungal medications
* Initiation of or changes to supplements or medications within 28 days prior to screening

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No