Abdominal Pain Response to a Two-Week Exclusive Palatable Elemental Diet in Irritable Bowel Syndrome

Presented at DDW 2026 | View Research | Watch Video

Overview

mBIOTA as a therapeutic tool for IBS. This is an examination of the same dataset from our 2023 clinical trial, but focusing on patients who met the IBS criteria. 22 out of 30 participants met the criteria for IBS. The FDA defines responders as anyone with a >30% decrease in the weekly average of daily worst abdominal pain from baseline at 5 weeks.

• IBS-C: 5 patients (constipation type)
• IBS-D: 4 patients (diarrhea type)

• IBS-M: 13 patients (mixed type)

Symptoms were evaluated as:

• Abdominal Pain
• Discomfort

• Distention

Note: >40% and >50% are also acceptable benchmarks, but since these are more difficult to achieve, they are rarely used. 

The criteria for IBS: Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:

• Related to defecation
• Associated with a change in the frequency of stool
• Associated with a change in the form (appearance) of stool

Results

At week 5, symptoms improved across all subtypes. Pain responder rates were 73% for ≥30% reduction (IBS-C 80%, IBS-M 77%, IBS-D 50%). Secondary symptom responders (≥30% improvement) were 64% for discomfort, 64% for distention, and 59% for bloating.

The percentage of participants who reached ≥30% improvement in at least one of the symptoms was 82% (100% IBS-C, 85% IBS-M, 50% IBS-D).

Why It Matters

We can now advertise mBIOTA for the management of IBS (in all 3 subtypes), with data backing our efficacy according to the FDA-aligned thresholds. We had high responder rates to this intervention, even when looking at response as a >40% and a >50% reduction in abdominal pain. IBS is a much larger market than SIBO and much more well-recognized, so this greatly increases our reach.