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

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511124-14-00

Enrollment

Registered

2024-05-28

Start date

2024-12-10

Completion date

Unknown

Last updated

2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative obesity

Brief summary

Safety and tolerability

Detailed description

PTH concentrations, Ca urinary excretion during 24 h, Bone resorption markers P1NP, CTX and BALP

Interventions

DRUGBAFA - Butyrate 90 mg and Glycocholate 480 mg Oral solution

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
PTH concentrations, Ca urinary excretion during 24 h, Bone resorption markers P1NP, CTX and BALP	—

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026