Study on Sodium Glycocholate and Sodium Butyrate for Calcium Absorption in Women with Obesity After Gastric Bypass

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for individuals who have undergone a specific type of weight-loss surgery known as Roux-en-Y gastric bypass. The treatment being tested is an oral solution called BAFA – Butyrate 90 mg and Glycocholate 480 mg, which contains two active substances: sodium glycocholate and sodium butyrate. These substances are being studied to see if they can help increase calcium absorption in the body.

The purpose of this study is to assess the safety and tolerability of the treatment when given in multiple doses. The trial involves healthy female participants who have had the surgery and are between the ages of 25 and 45. Participants will receive the treatment and be monitored to ensure it is safe and well-tolerated. The study will also look at how the treatment affects certain markers in the body, such as calcium levels and bone health indicators.

Throughout the study, participants will take the oral solution and undergo regular check-ups to monitor their health and any changes in their calcium absorption. The trial aims to provide valuable information on whether this treatment can be a safe and effective option for improving calcium absorption in individuals who have had Roux-en-Y gastric bypass surgery.

1 joining the trial

Upon joining the trial, the participant provides signed and dated written consent. This is a necessary step before any trial-specific procedures can begin.

2 initial assessment

The participant undergoes an initial assessment to confirm eligibility. This includes verifying age, health status, and previous medical procedures such as Roux-en-Y gastric bypass surgery performed over 12 months ago.

The participant must have a steady weight phase, with a body mass index (BMI) between 25 and 35 kg/m², and normal blood calcium levels.

3 medication administration

The participant receives the oral solution named BAFA, which contains butyrate 90 mg and glycocholate 480 mg. This solution is administered orally.

The medication is taken multiple times as part of the trial to assess its safety and tolerability.

4 monitoring and evaluation

Throughout the trial, the participant’s safety and tolerability to the medication are closely monitored.

Secondary evaluations include measuring parathyroid hormone (PTH) concentrations, calcium urinary excretion over 24 hours, and bone resorption markers such as P1NP, CTX, and BALP.

5 completion of trial

The trial is estimated to conclude by November 29, 2024. Upon completion, the participant’s involvement in the trial ends, and final assessments are conducted to ensure all objectives have been met.

Who Can Join the Study?

Provide signed and dated written consent before any study-specific procedures.
Be a healthy female between the ages of 25 and 45.
Be a healthy patient who had a surgery called RYGB (Roux-en-Y gastric bypass) more than 12 months ago, taking daily vitamins and minerals, not taking other medicines (except for stable medical conditions), with normal blood calcium levels, and low calcium in urine.
Have a stable weight, meaning your weight hasn’t changed more than 5 kg in the last 3 months, and have a body mass index (BMI) between 25 and 35. BMI is a measure of body fat based on height and weight.
Have a negative pregnancy test and use birth control.
Be able to understand and willing to follow the study procedures and requirements as determined by the study investigator.

Who Cannot Join the Study?

Only females can participate, so males are excluded.
Individuals who are not within the specified age range are excluded. The age range is not specified here, but it means that only people of certain ages can join.
People with medical conditions other than postoperative obesity are excluded. This means the study is only for those who have gained weight after surgery.
Vulnerable populations are not included. This usually refers to groups like children, pregnant women, or those unable to give consent, but specifics are not provided here.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	02.04.2024

Trial locations

Investigated drugs:

Glycocholate (GC) is a compound that is being tested to see if it can help increase calcium absorption in the body. It is being studied in women who have had a specific type of weight loss surgery called Roux-en-Y gastric bypass. The trial aims to determine if this compound is safe and well-tolerated when taken multiple times.

Butyrate (B) is another compound included in the trial to evaluate its potential to enhance calcium absorption. Like glycocholate, it is being tested in women who have undergone Roux-en-Y gastric bypass surgery. The focus is on understanding its safety and how well it is tolerated with repeated use.

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It typically develops when calorie intake exceeds calorie expenditure over time, leading to weight gain. The progression of obesity can result in increased body mass index (BMI) and may lead to various health complications. Factors contributing to obesity include genetics, lifestyle choices, and environmental influences. It often requires long-term management to address and control weight gain.

Trial ID:

2024-511124-14-00

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on Sodium Glycocholate and Sodium Butyrate for Calcium Absorption in Women with Obesity After Gastric Bypass

What is this study about?

Who Can Join the Study?

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