In short
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.
Key points
- Clinical trials of Sodium Butyrate in this data set are studying two very different postoperative settings. One early-phase trial is looking at safety and tolerability in healthy women after Roux-en-Y gastric bypass. Another Phase 3 trial is studying recovery of bowel function in patients with Hirschsprung’s disease after surgery. The studies are authorised and use small to moderate enrollment numbers. The main outcomes are safety in one trial and recovery time in the other. Overall, the research is focused on whether Sodium Butyrate may help with postoperative care in these specific groups.
Trial overview
Two authorised interventional trials are listed for Sodium Butyrate in the source data.
Both studies are focused on postoperative care, but they look at different patient groups and different clinical questions.
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.
This study tests multiple dosing of glycocholate and butyrate, given as an oral solution, with the goal of increasing calcium absorption.
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.
The trial plans to enroll 12 participants and is authorised.
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.
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.
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.
The trial plans to enroll 58 participants and is authorised.
Main outcomes being measured
The main outcome in the gastric bypass study is safety and tolerability after multiple dosing.
The main outcome in the Hirschsprung’s disease study is time to recovery of bowel function after curative surgery.
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.
Who can participate
The participant groups are narrow and specific in these trials.
- The first trial includes healthy female participants after Roux-en-Y gastric bypass.
- The second trial includes patients with Hirschsprung’s disease who are being studied around the time of surgery.
These studies do not describe broad public use; they are designed for specific clinical situations after surgery.
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.
Phase 3 studies are later trials. They usually include more people and focus more on whether the treatment works for the condition being studied.
In this data set, Sodium Butyrate is being studied across both early and later stages of clinical research.