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Tests treatment safety and results for Small Intestinal Bacterial Overgrowth
Official title The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
ClinicalTrials.gov ID: NCT06317441
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Aged 18-65 years old at the inclusion of the study, both female and male people.
- 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.
You likely can't join 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...
- 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.
See the full eligibility criteria
Who can join
- Aged 18-65 years old at the inclusion of the study, both female and male people.
- 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).
What rules you out
- 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...
- 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...
- 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,
- Participants over the age of 50 or older who have not had:
- a colon cancer screening by either a negative FIT or FOBT test within the last 2 years; OR
- a colonoscopy in the prior 10 years which was negative for colorectal cancer
- Epilepsy diagnosis.
- History or diagnosis of immunological diseases, infectious diseases or immune-compromised conditions, which in the opinion of the investigator, would adversely affect study safety or outcome. Such as, but not limited...
- History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
- Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
- Regular use of probiotics, prebiotics or synbiotics (including food and drinks containing added probiotics and/or probiotic yogurts with live, active cultures) within 1 month prior to screening. Potential participants...
- Any prior Fecal Microbiota Transplantation.
- Pregnant or breastfeeding.
- Planning to become pregnant.
- Alcohol or drug abuse.
- Allergy to the components present in the probiotic and placebo capsules.
- Are non-English speaking.
- Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.