FMT capsule + SIMBA Capsule for Obsessive-Compulsive Disorder

Phase-Based Progress Estimates
University of Calgary, TRW building, Calgary, CanadaObsessive-Compulsive DisorderFMT Capsule + SIMBA Capsule - CombinationProduct
18 - 65
All Sexes
What conditions do you have?

Study Summary

This trial is studying if gut bacteria from healthy donors can help people with OCD. It will use stool analysis and SIMBA capsules to measure changes in the gut microbiome.

Eligible Conditions
  • Obsessive-Compulsive Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 0-13 weeks

0-13 weeks
Adverse Events
Global function/overall improvement (Patient Health Questionnaire-9(PHQ9))
Global function/overall improvement (Positive and Negative Affect Schedule (PANAS))
Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS))
Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7))
Next generation fecal, Urine, Blood and saliva sequencing
OCD symptoms (TOCS)
OCD symptoms (Y-BOCS)
Toronto Side Effects Scale (TSES)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

FMT capsule + SIMBA Capsule
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: FMT capsule + SIMBA Capsule · No Placebo Group · Phase 2

FMT capsule + SIMBA Capsule
Experimental Group · 1 Intervention: FMT Capsule + SIMBA Capsule · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0-13 weeks

Who is running the clinical trial?

Valerie TaylorLead Sponsor
2 Previous Clinical Trials
215 Total Patients Enrolled
Nimble Science Ltd.Industry Sponsor
3 Previous Clinical Trials
200 Total Patients Enrolled
University of CalgaryOTHER
717 Previous Clinical Trials
574,262 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
201 Patients Enrolled for Obsessive-Compulsive Disorder
Valere Taylor, MD,PhD,FRCPCPrincipal InvestigatorProfessor, Head of Department

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are an adult who has been diagnosed with OCD as your main condition.
Your current medication for depression (SSRI) is not working well enough and you still have symptoms.

Frequently Asked Questions

What potential adverse effects could arise from the combination of FMT capsule and SIMBA Capsule?

"The existing evidence on FMT capsule + SIMBA Capsule's safety is sufficient to warrant a score of 2. This Phase 2 trial has not yet produced any data regarding the medication's efficacy, but there are multiple studies indicating its safety profile." - Anonymous Online Contributor

Unverified Answer

Does the study requirements include elderly participants aged 85 and over?

"This clinical trial has a narrow age range of 18 to 65. However, there are additional studies dedicated specifically for those under 18 and over 65 respectively; 20 trials and 67 trials in total." - Anonymous Online Contributor

Unverified Answer

Are new participants still being sought for this scientific endeavor?

"As per, the recruitment for this medical trial has closed since the last changes made to it were on February 7th 2023. Nonetheless, there are currently 106 other trials actively searching for participants." - Anonymous Online Contributor

Unverified Answer

What are the desired outcomes of this experiment?

"The primary outcome metric for this Nimble Science Ltd.-sponsored study, evaluated over a 0-13 week period of time, is the Toronto Side Effects Scale (TSES). Additionally, secondary assessments will be conducted to gauge Global function/overall improvement; these include The General Anxiety Disorder-7 scale (GAD-7), Positive and Negative Affect Schedule (PANAS) as well as Patient Health Questionnaire-9(PHQ9)." - Anonymous Online Contributor

Unverified Answer

Am I eligible to enroll in this clinical experiment?

"This clinical trial is enrolling 20 individuals between the ages of 18 and 65 who have been diagnosed with Obsessive Compulsive Disorder (OCD). To be eligible, patients must also meet the following requirements: a confirmed OCD diagnosis, at least 12 weeks of SSRI treatment prior to baseline assessment, and evidence that their current medication has not adequately managed symptoms." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.