Dietary Intervention Detection in the Small Intestine

NCT04489329 | Completed DMC

• 1 other identifier: REB 20-1211
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bacterial density count

  density count of probiotic strain compared between capsule and stool sample (CFU/ml)

  7 days

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Device: Ingestible Capsule; Dietary Supplement: Probiotic

Interventions

Ingestible Capsule DEVICE

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

Single Arm

Probiotic 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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old
• Healthy
• On no medication, or on stable doses of medications which will not be changed over the course of the study
• Willingness to maintain their usual dietary habits and physical activity
• 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.
• Ability to understand and provide informed consent
• Ability and willingness to meet the required schedule and study tasks and interventions
• Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)

You may not qualify if:

• History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
• Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
• Use of other investigational product within 3 months of start of the study.
• Suffering from immune disorders or with possible immune deficient status
• Allergy to soy or milk.
• 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).
• 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).
• Body Mass Index (BMI) \> 38.
• Previous history of gastric bezoar or gastroparesis.
• Any abdominal or pelvic surgery within the past 3 months.
• Known history of inflammatory bowel disease and/or Crohn's disease.
• History of diverticulitis, diverticular stricture, or other intestinal strictures.
• History of abdominal or pelvic radiotherapy.
• History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.
• Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.

Sponsors & Collaborators

• Nimble Science Ltd.: lead
• University of Calgary: collaborator
• Lallemand Health Solutions: collaborator

Study Sites (1)

Cumming School of Medicine

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chris Andrews, MD MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: December 22, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)