The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms

NCT06317441 | Recruiting DMC

• 1 other identifier: NIMCSF137
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms, gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth (SIBO). Two doses of probiotic will be evaluated against placebo.

Conditions

Small Intestinal Bacterial Overgrowth; SIBO

Keywords

Functional abdominal bloating and distension; Functional Diarrhea; Irritable Bowel Syndrome with Diarrhea; Irritable Bowel Syndrome; Abdominal Bloating; IBS; IBS-D; FABD; Functional Gastrointestinal Disorders; FGID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Median bloating-free days

  Each intervention week and follow up (week 12) compared to baseline.

• Change in median bloating/distension severity

  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.

• Change in abdominal discomfort/pain

  At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline

• Changes in gastrointestinal symptoms

  At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.

• Changes in stool frequency and consistency

  At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.

Other Outcomes (3)

• Exploratory metabolomic analysis

  Through study completion, an average of 1 year

• Exploratory: Quantifying the probiotic cell proportions

  Through study completion, an average of 1 year

• Safety outcomes

  Through study completion, an average of 1 year

Study Arms (3)

Probiotic (High dose)

EXPERIMENTAL

A high dosage probiotic per capsule

Dietary Supplement: Probiotic

Probiotic (Low dose)

EXPERIMENTAL

A low dosage probiotic per capsule

Dietary Supplement: Probiotic

Control group (Placebo)

NO INTERVENTION

No probiotic dosage

Interventions

Probiotic DIETARY_SUPPLEMENT

The intervention consists of a probiotic either with a low or high dosage

Probiotic (High dose); Probiotic (Low dose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent; willing and able to comply with study procedures.
• Willing to maintain their diet and physical activity levels during the study.
• Able to swallow a size-00 capsule (23mm length and 9mm width).
• Participants with at least one of the following Rome IV diagnoses: FABD, functional diarrhea, IBS-M, or IBS-D.
• Baseline weekly average of worst daily (in past 24 hours) abdominal bloating/distension score of \>= 3.0 on a 0-to-10-point scale.
• Participants with abnormal LHBT following the North American Consensus recommendations (A rise in hydrogen of ≥20 ppm by 90 min).

You may not qualify if:

• History of less than three (3) bowel movements per week.
• With the diagnosis of IBS-C.
• Prior gastrointestinal disease, surgery, or abdominal or pelvic 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.
• Persons with central venous catheters.
• History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.
• Known history abdominal radiation treatment.
• 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, anticholinergics, or GLP-1 analogues); laxative use is allowed if used less than 3 times a week and it is willing to keep unchanged in the week prior to the SIMBA capsule ingestions. 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.
• o Prokinetic use. Potential participants who are not using prokinetics to treat SIBO may be eligible after a 2-week washout period, and willing to not use prokinetics for the study duration.
• Unable to stop using laxatives or prokinetic medications for 4 days before the study procedure (BT). Laxatives can be resumed after the test is conducted.
• Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
• Celiac disease (treated or untreated).
• 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.
• Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).
• Gastrointestinal inflammatory diseases, including ulcerative colitis, Crohn's disease, microscopic colitis.
• Participants with IBS presenting with alarm symptoms such as: rectal bleeding, unexplained weight loss, iron deficiency anemia, and nocturnal symptoms,

Sponsors & Collaborators

• Nimble Science Ltd.: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

Nimble Science

Calgary, Alberta, T2L 1Y8, Canada

RECRUITING

MeSH Terms

Conditions

Dilatation, Pathologic; Irritable Bowel Syndrome; Gastrointestinal Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Gwen Duytschaever, PhD

CONTACT

8664934633; clinical@nimblesci.com

Isaac Wong, MBT

CONTACT

8664934633; clinical@nimblesci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 19, 2024
• Study Start: July 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)