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OpenTrials
Completed

NCT Number: NCT04489329

Dietary Intervention Detection in the Small Intestine

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cumming School of Medicine

Calgary, Alberta, T2N 4Z6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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)

Exclusion criteria

  • 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.
  • Colon cleansing prep for 1 month before the first visit, or during the study.
  • Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.
  • < 2 bowel movements per week.

Treatment and study plan

Ingestible Capsule

Device

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

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.

Primary outcomes

  1. Bacterial density count

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Nimble Science Ltd.

Industry

Collaborators

  • Lallemand Health Solutions
  • University of Calgary

Registry information

Official study title

Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2020
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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