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New treatment option for Bile Acid Malabsorption
Official title Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
ClinicalTrials.gov ID: NCT06609148
What this study is testing
- What it's testing
- The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Prior diagnosis of bile acid malabsorption documented in the medical history based on
- either serum C4 \>52.5ng/mL, or
- fecal 48h total BA excretion \>2337 μmol/48h, or
- primary BA \>5% 48h stool collection or \>10% in single stool sample.
- 7-day stool dairy with an average stool consistency based on the Bristol Stool Form Scale, BSFS, with a grade greater than 5. Note: If 3 is not met...
You likely can't join if
- Use of oral antibiotics and probiotics within the last 4 weeks.
- Pregnancy or lactation.
- Concomitant use of bile acid sequestrants, must stop 10 days before starting 7-day stool dairy and for the duration of the study.
- History of ileal resection.
- Diabetes mellitus (type 1)
- BMI ≥ 40 kg/m\^2
See the full eligibility criteria
- Prior diagnosis of bile acid malabsorption documented in the medical history based on
- either serum C4 \>52.5ng/mL, or
- fecal 48h total BA excretion \>2337 μmol/48h, or
- primary BA \>5% 48h stool collection or \>10% in single stool sample.
- 7-day stool dairy with an average stool consistency based on the Bristol Stool Form Scale, BSFS, with a grade greater than 5. Note: If 3 is not met, participants may choose to have their blood drawn clinically to...
- For women of childbearing potential
- A negative urine pregnancy test prior to dispensing the study product
- Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as...
- Surgical sterilization
- Hormonal contraception (implantable, patch, oral, intra-muscular)
- Intra-uterine device
- Double barrier method (diaphragm plus condom)
- At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance
- Use of oral antibiotics and probiotics within the last 4 weeks.
- Pregnancy or lactation.
- Concomitant use of bile acid sequestrants, must stop 10 days before starting 7-day stool dairy and for the duration of the study.
- History of ileal resection.
- Diabetes mellitus (type 1)
- BMI ≥ 40 kg/m\^2
- Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac diseases or gastrointestinal infection in the prior 4 weeks
- Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol or could interfere with the study assessments
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. 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.