An open-label, non-randomised safety and tolerability Proof of Concept Trial to examine multiple dosing addition of glycocholate (GC) and butyrate (B) to increase Ca absorption in healthy female participants that have undergone Roux-en-Y gastric bypass (BAFA)
- Conditions
- Postoperative obesityTherapeutic area: Diseases [C] - Digestive System Diseases [C06]Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2024-511124-14-00
- Lead Sponsor
- Vaestra Goetalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Provision of signed and dated, written informed consent prior to any study specific procedures., Healthy female subjects =25 years of age =45 years of age., Healthy operated patients with RYGB >12 months ago on daily micronutrient substitution free from medicines (medicines for steady state medical conditions allowed) with normal blood calcium, PTH from the upper quartile Trial ID: BAFA Version No: 1 Date: February 2024 EU Trial No: 2024-511124-14-00 13 (48) of the normal range and higher (?10,1 pmol/L, reference range 1.8 -11 pmol/L), low 24 h urinary calcium (<50mg/day) in the lower interval of the reference range (reference range 0,7–7 mmol/d; 28–280 mg), vitamin D and calcium supplementation and ability to take BAFA., Have a steady weight phase (weight within 5 kg variation within last 3 months) and a body mass index from = 25 to = 35 kg/m2, Females must have a negative pregnancy test and use anticonceptives., Subjects must be able to understand and willing to comply with study procedures, restrictions and requirements as judged by the investigator.
Women with a positive pregnancy test on enrolment or lactating women., History of hypersensitivity and allergy, as judged by the investigator, Subjects not tolerating injections, endoscopies, enteroscopies or mucosal biopsies., Complicated RYGB (for example failed primary operation or severe postop complications that affect GI function)), other previous surgeries in the abdomen (appendectomy/cholecystectomy allowed) or severe abdominal complaints., Subjects not tolerating taste of IMP, Have previous (<12 months) treatments that may have had impact on bone metabolism., Have other conditions that make principal investigator insecure on study participation., Involvement in the planning, and/or conduct of the study, Previous enrolment or randomization in the present study, Participation in another clinical study with an IMP during the last 3 months prior to enrolment., History of any unstable medical disease which may interact with the objective of the study or with the safety of the subject, as judged by the investigator, History of any psychiatric disease that could preclude reliable participation in the study, as judged by the investigator., Clinically significant illness within 2 weeks before the administration of the IMP as judged by the investigator., Donation of plasma from 2 weeks before Visit 1 or donation of blood from 3 months from Visit 1., Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the investigator., Immunisation with live vaccine within the previous 3 months, for other vaccines within the past 30 days., Subjects with active infectious disease or infections that warrants special infection control measures, such as human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection., History of alcohol or drug abuse within 2 years of entering the study, History of positive test of covid-19 and as judged by the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method