The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms

Small Intestinal Bacterial Overgrowth Clinical Trial

Official title:

The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317441
• Other study ID #: NIMCSF137
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Nimble Science Ltd.
• Contact: Gwen Duytschaever, PhD
• Phone: 4037032436
• Email: gwen[@]nimblesci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the goal is to evaluate whether a probiotic formula may reduce symptoms of bloating and abdominal distension in a population suffering from Small Intestinal Bacterial Overgrowth (SIBO) in comparison to a placebo. In addition to the incidence of SIBO, changes to other gastrointestinal symptoms will be assessed. Lastly, the associations between the SIBO status and microbiome from the small and large intestines will be explored using the SIMBA capsule.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Aged 18-55 years old at the inclusion of the study, both female and male subjects.

2. Signed Informed Consent; willing and able to comply with study procedures.

3. Willing to maintain their diet and physical activity levels during the study.

4. Able to swallow a size-00 capsule (23mm length and 8mm width).

5. Participants with a Rome IV diagnosis of FABD, functional diarrhea, or IBS-D.

6. Baseline weekly average of worst daily (in past 24 hours) abdominal bloating/distension score of >= 3.0 on a 0-to-10-point scale.

7. Participants SIBO-positive as measured with the Glucose Breath Test following the North American Consensus recommendations (A rise in hydrogen of =20 p.p.m. by 90 min).

Exclusion Criteria:

1. Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, any IBD, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.

2. Persons with central venous catheters.

3. History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.

4. Known history abdominal radiation treatment.

5. Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the study visit. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.

6. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.

7. Celiac disease (treated or untreated).

8. Any significant heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.

9. Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).

10. Gastrointestinal inflammatory diseases, including ulcerative colitis, Crohn's disease, microscopic colitis.

11. Epilepsy diagnosis.

12. History or diagnosis of immunological or infectious disease (hepatitis, tuberculosis, HIV, Parkinson's).

13. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.

14. With the diagnosis of IBS-C.

15. Antibiotic use (except for topical use) = 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.

16. Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.

17. Any prior Fecal Microbiota Transplantation.

18. Pregnant or breastfeeding.

19. Planning to become pregnant.

20. Alcohol or drug abuse.

21. Milk or soy allergy.

22. Are non-English speaking.

Related Conditions & MeSH terms

• Small Intestinal Bacterial Overgrowth

Intervention

Dietary Supplement:
• Probiotic
The intervention consists of a probiotic either with a low or high dosage

Locations

Country	Name	City	State
Canada	Nimble Science	Calgary	Alberta
Canada	Nimble Science	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Nimble Science Ltd.	Lallemand Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory metabolomic analysis	To investigate whether certain metabolites present in the small intestine, fecal, saliva samples may be associated with the presence/absence of SIBO. Using untargeted metabolomic methodologies.	Through study completion, an average of 1 year
Other	Exploratory: Quantifying B. subtilis cell proportions	Determine the proportion of B. subtilis cells in spore versus germinated form using qPCR methodologies	Through study completion, an average of 1 year
Other	Safety outcomes	To collect safety data on the probiotic formulation and the SIMBA capsule by monitoring adverse events throughout the study.	Through study completion, an average of 1 year
Primary	Change in bloating/distension severity	The primary outcome will assess the changes in weekly median severity of bloating/distension, defined as pressure, fullness or sensation of increased girth with a daily assessment with an ordinal scale between probiotic groups and placebo.	From baseline to end of intervention (week 8).
Secondary	Median bloating-free days	Median bloating-free days per week at each intervention week and follow up	Each intervention week and follow up (week 12) compared to baseline.
Secondary	Change in median bloating/distension severity	Change in median bloating/distension severity assessed by an ordinal scale (0 no severity- 10 extreme severity) at all intervention weeks (with the exception of end-of-intervention, as described in the primary outcome)	At all intervention weeks (with the exception of end-of-intervention, as described in the primary outcome) and follow-up (week 12) compared to baseline.
Secondary	Change in abdominal discomfort/pain	Change in abdominal discomfort/pain assessed by an ordinal scale (0 no pain - 10 extreme pain)	At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline
Secondary	Changes in gastrointestinal symptoms	Changes in gastrointestinal symptoms assessed with GSRS	At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Secondary	Changes in stool frequency and consistency	Changes in stool frequency and consistency assessed with the Bristol Stool Scale (scoring 1 watery - 7 hard)	At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Secondary	Changes in the quality of life	Changes in the quality of life assessed with the Short Form (SF)-36 questionnaire	At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Secondary	Changes in reflux incidence and severity	Changes in reflux incidence and severity assessed with the modified reflux symptoms (mRESQ)	At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Secondary	Changes in the severity of IBS symptoms	Changes in the severity of IBS symptoms assessed with IBS Severity Scoring System (IBS-SSS) questionnaire	At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Secondary	Recovery rate of the probiotic strain	Recovery rate of the probiotic strain in small intestine and stool specimens	At mid-intervention (week 4) end of intervention (week 8), and follow-up (week 12) compared to baseline.
Secondary	Microbiome changes within small intestine, fecal and saliva samples	Changes in the the bacterial populations with the small intestine, fecal and saliva microbiomes represented as a diversity ratio	At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Secondary	Investigation how the microbiome and SIBO associate with each other though bacterial population analyses.	Exploring the correlation of select bacterial populations with SIBO through analysis of the small intestine and fecal microbiomes using metagenomics methodologies.	Through study completion, an average of 1 year
Secondary	Change in SIBO positivity rate	Change in SIBO positivity rate assessed by glucose breath test	Through study completion, an average of 1 year