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Sodium Butyrate

Clinical trials of Sodium Butyrate are looking at different patient groups and different goals. The studies in this article focus on safety, tolerability, and recovery of bowel function in people after surgery, including healthy women after gastric bypass and patients with Hirschsprung’s disease.

Table of Contents

Trial overview

Two authorised interventional trials are listed for Sodium Butyrate in the source data.[1][2]

Both studies are focused on postoperative care, but they look at different patient groups and different clinical questions.[1][2]

Study in postoperative obesity after gastric bypass

One trial is an open-label, non-randomised proof-of-concept study in healthy female participants who have undergone Roux-en-Y gastric bypass, a type of weight-loss surgery.[1]

This study tests multiple dosing of glycocholate and butyrate, given as an oral solution, with the goal of increasing calcium absorption.[1]

The study is in Phase 1/2, which means it is an early clinical trial that first looks at safety and tolerability and may also explore whether the approach shows early signs of benefit.[1]

The trial plans to enroll 12 participants and is authorised.[1]

Study in Hirschsprung’s disease after surgery

The second trial studies the effects of butyrate enemas on postoperative intestinal motility disorders in patients with Hirschsprung’s disease.[2]

The brief summary says the trial aims to assess the short-term efficacy of preoperative butyrate enemas in reducing the time to recovery of bowel function after curative surgery.[2]

This study is in Phase 3, which usually means a later-stage trial with more participants and a stronger focus on how well the treatment works.[2]

The trial plans to enroll 58 participants and is authorised.[2]

Main outcomes being measured

The main outcome in the gastric bypass study is safety and tolerability after multiple dosing.[1]

The main outcome in the Hirschsprung’s disease study is time to recovery of bowel function after curative surgery.[2]

In simple terms, these outcomes ask two different questions: can the treatment be used safely, and can it help the bowel recover faster after surgery.[1][2]

Who can participate

The participant groups are narrow and specific in these trials.[1][2]

  • The first trial includes healthy female participants after Roux-en-Y gastric bypass.[1]

  • The second trial includes patients with Hirschsprung’s disease who are being studied around the time of surgery.[2]

These studies do not describe broad public use; they are designed for specific clinical situations after surgery.[1][2]

Trial phases and what they mean

Phase 1/2 studies are early trials. They often start by checking safety, tolerability, and whether the treatment seems promising enough for more research.[1]

Phase 3 studies are later trials. They usually include more people and focus more on whether the treatment works for the condition being studied.[2]

In this data set, Sodium Butyrate is being studied across both early and later stages of clinical research.[1][2]

Trial ID Phase Condition studied Status Enrollment Primary outcome
2024-511124-14-00 Phase 1/2 Postoperative obesity Authorised 12 Safety and tolerability
2025-523094-42-00 Phase 3 Hirschsprung’s disease Authorised 58 Time to recovery of bowel function after the curative surgery

FAQ

  • What are clinical trials of Sodium Butyrate studying? These trials are studying whether Sodium Butyrate can be used safely and whether it may help with specific recovery problems after surgery. The goals include safety, tolerability, and time to return of bowel function.
  • Who can take part in these trials? The target groups are different in each study. One trial includes healthy female participants after Roux-en-Y gastric bypass, and another includes patients with Hirschsprung’s disease.
  • What trial phases are listed for Sodium Butyrate studies? The trials are in Phase 1/2 and Phase 3. Early-phase studies usually look first at safety and tolerability, while later-phase studies focus more on how well the treatment may work.
  • What conditions are being studied? The trials in this data set study postoperative obesity after gastric bypass and Hirschsprung’s disease. Both studies focus on recovery after surgery.
  • What outcomes are measured in these trials? One trial measures safety and tolerability after multiple dosing. The other measures the time to recovery of bowel function after curative surgery.

Ongoing Clinical Trials on Sodium Butyrate

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

    Recruiting

    1 1
    Investigated drugs:
    Sweden

  • Study of sodium butyrate enemas for bowel function recovery after surgery in children and adults with Hirschsprung’s disease

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    France

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, helpful, or both.
  • Open-label: A study where both the researchers and participants know what treatment is being given.
  • Non-randomised: A study where participants are not assigned to groups by chance.
  • Safety: How well a treatment can be used without causing unacceptable problems.
  • Tolerability: How well people can handle a treatment, including whether they can continue it.
  • Phase 1/2: An early study phase that looks at safety first and may also begin to look at whether the treatment may help.
  • Phase 3: A later study phase that usually includes more people and looks more closely at how well a treatment works.
  • Primary outcome: The main result the trial is designed to measure.
  • Bowel function: How well the intestines are working, including movement of stool through the gut.
  • Hirschsprung’s disease: A condition that affects the bowel and can cause problems with passing stool.
  • Roux-en-Y gastric bypass: A type of weight-loss surgery that changes the way the stomach and intestines are connected.

References

  1. https://clinicaltrials.gov/study/2024-511124-14-00
  2. https://clinicaltrials.gov/study/2025-523094-42-00