Clinical trial NCT05844826: Evaluation of the Microbiome in Multiple Sclerosis
Official title: A Clinical Study To Evaluate Small Intestine Microbiome In Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Nimble Science Ltd.
Sponsor class: INDUSTRY
Collaborators: name: IGY Life Sciences
First posted: 2023-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To access the small intestinal microbiome and find abnormal microbiome/metabolome signature in luminal fluid samples from small bowel in MS compared to HC that could be used as biomarkers for MS.

Detailed description: Participants will be swallowing the SIMBA capsule which allows for minimally-invasive sampling of the microbiome and metabolome deep in the small intestine. Researchers will use the capsule samples to access the small intestinal microbiome and find abnormal metabolomic signatures in luminal fluid samples from the small bowel in Multiple Sclerosis (MS) patients compared to healthy control.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 60 years inclusive.
2. Have diagnosis of Multiple Sclerosis (relapsing remitting or secondary progressive for the MS cohort) or be a healthy individual living in the same household (non-MS for the healthy control cohort)
3. No antibiotics, or colon cleanses/bowel preparation in the previous 2 weeks.
4. Written informed consent

Exclusion Criteria:

1. Known to have swallowing disorders
2. Known disease which, in the investigator's opinion, would lead to intestinal stricture or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, diverticulitis, Crohn's disease, Ulcerative colitis, cancer diagnosis or treatment within the past year, or previous oesophageal, gastric, small intestinal, or colonic surgery. 3) Appendectomy or cholecystectomy more than 3 months prior to enrolment are acceptable). The main deciding factor would be history of obstructive symptoms in the previous 3 months prior to entry.
3. Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA); for both groups.
4. \< 2 bowel movements per week (for both groups).
5. Risk or suspect of being pregnant

Primary outcomes:
measure: 16s microbiome sequencing and LC-MS metabolomic analysis will be performed on these samples to compare gut microbiome and metabolite profiles of healthy control and diagnosed MS patients
timeFrame: baseline
measure: Comparison of blood samples from Multiple Sclerosis (MS) and healthy control participants for biomarkers of inflammation, as analysed using ELISA, protenomic methods, and commercially available assays.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Carlos Camara-Lemarroy
role: PRINCIPAL_INVESTIGATOR
References: