Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
De Simone formulation probiotic
Dietary supplementSubjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days
Placebo
Dietary supplementSubjects will be given a placebo for 21-24 days
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Probiotic GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in fecal bile acid concentration
Reported as micromoles per g stool and % primary bile acids
Time frame
Baseline, 24 daysSecondary outcomes
1
Change in intestinal permeability
Intestinal permeability will be measured using the standardized, validated 13C-mannitol and lactulose urine excretion test and reported as a ratio of the percentage excretion of lactulose and mannitol in urine
Time frame
Baseline, 24 daysOther outcomes
1
Changes in symptoms based on daily stool diary acquired for 7 days' baseline and the 21 days of intervention
The stool diary will measure stool consistency based on the Bristol Stool Form Scale (BSFS) from 1 to 7 where 7 is watery stool and 1 is hard stool and therefore a small number indicated a favorable outcome
Time frame
Baseline, 24 daysSponsors and contacts
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Source ClinicalTrials.gov