Active, not recruitingPhase 1/2
Tests glycocholate and butyrate for calcium absorption after gastric bypass surgery
Tests glycocholate and butyrate for safety in women after gastric bypass surgery.
Key facts
- Who runs it
- Vaestra Goetalandsregionen
- Where
- Gothenburg, SwedenSee the site
- Trial code
- Registry title
- 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)
- Status
- Active, not recruiting
- Phase
- Phase 1/2
- People taking part
- 12 people, planned
- Started
- 10 Dec 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Record updated
- 27 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults who had a Roux-en-Y gastric bypass (RYGB) more than 12 months ago and have normal blood calcium. It tests the safety of glycocholate (GC) and butyrate (B).
- Age
- 20 to 65 years (the record also lists 18 to 64 years)
- Sex
- Women and men can join.
- Disease stage
- Gastric bypass (RYGB) more than 12 months ago, no serious problems from the surgery; steady weight in the last 3 months; body mass index from 20 to 45 kg/m2.
- Earlier treatment
- Daily micronutrient supplements and calcium supplements. No medicines except those for steady long-term conditions. No treatment that may affect bone metabolism in the last 12 months.
- Biomarker or test result
- Normal blood calcium and vitamin D. Women need a negative pregnancy test.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Complicated gastric bypass or other earlier abdominal surgery
- Active infectious disease such as HIV, tuberculosis, or chronic hepatitis B or C
- Unstable medical disease or psychiatric disease that could affect taking part
- Alcohol or drug abuse within the last 2 years
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy female and male subjects ≥20 years of age ≤65 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, 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 ≥ 20 to ≤ 45 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
Who cannot take part
- 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
- Have previous (<12 months) treatments that may have had impact on bone metabolism
- Previous enrolment or randomization in the present study
- Participation in another clinical study with an IMP during the last 3 months prior to enrolment
- 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
- Immunisation with live vaccine within the previous 3 months, for other vaccines within the past 30 days
- History of hypersensitivity and allergy, as judged by the investigator
- Have other conditions that make principal investigator insecure on study participation
- 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
- 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
- Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the investigator
- Women with a positive pregnancy test on enrolment or lactating women
- Subjects not tolerating injections
- Subjects not tolerating taste of IMP
- Involvement in the planning, and/or conduct of the study
Where in Sweden
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGothenburg, SwedenNo longer taking part
About the trial
What the trial wants to find out
The primary objective of this trial is to assess the safety and tolerability of GC and B following administration of multiple dosing.
Data and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests glycocholate and butyrate for calcium absorption after gastric bypass surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 27 August 2025