Dietary Intervention Detection in the Small Intestine

NCT ID: NCT04489329

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2021-02-24

Brief Summary

Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.

Conditions

Proof of Concept

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Arm

Participant swallows and retrieves capsule in stool before and after ingestion of a probiotic. Capsule and stool samples are analyzed for presence of probiotic strain and compared to baseline.

Group Type: EXPERIMENTAL

Ingestible Capsule

Intervention Type: DEVICE

Participants will swallow capsule and undergo X-rays to establish transit

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.

Interventions

Ingestible Capsule

Participants will swallow capsule and undergo X-rays to establish transit

Intervention Type: DEVICE

Probiotic

Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. 18 to 65 years old

2. Healthy

3. On no medication, or on stable doses of medications which will not be changed over the course of the study

4. Willingness to maintain their usual dietary habits and physical activity

5. Willing to discontinue consumption of fermented foods or probiotics (such as kombucha, yogurts with live, active cultures, or probiotic supplements) for the duration of the study.

6. Ability to understand and provide informed consent

7. Ability and willingness to meet the required schedule and study tasks and interventions

8. Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)

Exclusion Criteria

1. History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).

2. Pregnant or breastfeeding or planning on becoming pregnant during study timeline.

3. Use of other investigational product within 3 months of start of the study.

4. Suffering from immune disorders or with possible immune deficient status

5. Allergy to soy or milk.

6. Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach or small or large intestine (exceptions include appendectomy or cholecystectomy more than 3 months prior to enrollment).

7. Use of any medications in the previous 7 days that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives), acidity (PPI, H2RA), or integrity (NSAIDs, oral steroids).

8. Body Mass Index (BMI) > 38.

9. Previous history of gastric bezoar or gastroparesis.

10. Any abdominal or pelvic surgery within the past 3 months.

11. Known history of inflammatory bowel disease and/or Crohn's disease.

12. History of diverticulitis, diverticular stricture, or other intestinal strictures.

13. History of abdominal or pelvic radiotherapy.

14. History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.

15. Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.

16. Colon cleansing prep for 1 month before the first visit, or during the study.

17. Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.

18. < 2 bowel movements per week.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

Lallemand Health Solutions

INDUSTRY

Sponsor Role: collaborator

Nimble Science Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Andrews, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Cumming School of Medicine

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB 20-1211

Identifier Type: -

Identifier Source: org_study_id