GlutDigest - Pilot Study (GlutDigestP)

Deerland Probiotics & Enzymes

Status: Completed

Conditions: Main Focus: Gluten and Starch Digestibility

Treatments: Other: Meal A; Dietary Supplement: DE111®; Dietary Supplement: Glutalytic®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04489836

Project 0470-Pilot study

Details and patient eligibility

About

This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted.

Full description

Two important factors can influence the proportions of gluten and starch that resist digestion: (1) enzyme availability and specificity and (2) the structural properties of the food. A complete evaluation of gluten digestion and of the impact of dietary supplements is difficult to conduct because it is not easy to obtain samples of digestive chime. The analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive alternative to intubation techniques for the study of nutrient digestion and of the fate of probiotics in the small intestine.

The main aim of this study is to test and optimize sample analysis protocols before conducting the full-scale, crossover study which will aim at evaluating the impact of two dietary supplements (Glutalytic® and DE111®) and of oatmeal properties on the digestion of gluten and starch and on the glycemic response.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject has given written informed consent
• Subject has an ileostomy stable for at least 3 months post-operative and shows normal stoma functions
• Subject is otherwise healthy
• Subject is available to participate in the study sessions on the proposed dates

Exclusion criteria

• Subject has coeliac disease or allergy to wheat products and/or any other ingredients in the test meal and standard meals
• Case of obstruction of the stoma in the past 3 months
• Body mass index < 18 kg/m2 or > 30 kg/m2.
• Diagnosed mouth, throat or active gastrointestinal pathology (other than ileostomy) that may affect normal ingestion and digestion of food.
• History of pancreatic disease
• Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year)
• Subject has Type 1 or Type 2 diabetes mellitus.
• Subject has a history of bariatric surgery.
• Subject has a history of drug and/or alcohol abuse at the time of enrolment
• Subject is currently participating in another study, or plans to participate in another study during the study period
• Women of child-bearing potential who do not use an acceptable method of contraception
• Pregnant or nursing (lactating) women

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Meal A + Glutalytic®

Experimental group

Description:

350 mg Glutalytic® capsule, taken by mouth, once, with Meal A

Treatment:

Dietary Supplement: Glutalytic®

Other: Meal A

Meal A + DE111®

Experimental group

Description:

350 mg DE111® capsule, taken by mouth, once, with Meal A

Treatment:

Dietary Supplement: DE111®

Other: Meal A