Backed by Science. Built for Patients.

Clinical Trial Evidence






At mBIOTA Labs, we create clinically proven medical foods for patients with GI disorders - combining scientific rigor with empathy and respect for the patient experience.

2023 Prospective Clinical Study

As published in Clinical Gastroenterology and Hepatology

Effect, Tolerability, and Safety of Exclusive Palatable Elemental Diet in Patients with Intestinal Microbial Overgrowth

Our 2023 clinical trial of a 2-week course of mBIOTA in SIBO and IMO patients. The mBIOTA Elemental diet was tolerated by 100% of patients, eradicated overgrowth in 73% of patients overall and provided adequate relief from symptoms in 83% of patients.

CLINICALLY PROVEN FOR SIBO AND IMO¹

In a Cedars-Sinai clinical study, the mBIOTA Elemental diet eradicated SIBO in 83% of patients.  

A 2023 clinical trial at Cedars-Sinai in Los Angeles evaluated the mBIOTA Elemental Diet and demonstrated consistent eradication outcomes across patients with SIBO, IMO, or both.

Clinical Eradication Rates by Patient Cohort
SIBO Only
100%
SIBO Overall (SIBO + SIBO/IMO)
83%
SIBO/IMO Only
73%
IMO Overall (IMO + SIBO/IMO)
63%
IMO Only
58%
Based on normalization of patient’s lactulose breath test after day 14 of exclusive elemental diet.


These findings support hundreds of other clinical studies (across five decades) that have also found that elemental diets can relieve symptoms of GI conditions like IMO and SIBO.²

CLINICAL RESULTS

Participants reported up to an 82% reduction in 12 common GI symptoms.

Over the past 50 years, hundreds of clinical studies have shown that Elemental Diets help reduce symptoms of chronic GI conditions, including IBS and SIBO.²

In the 2023 clinical trial at Cedars-Sinai in Los Angeles, 83% of patients who completed two weeks of an exclusive elemental diet reported symptom relief that continued to improve even two weeks after diet completion.

Symptom Reduction after mBIOTA Elemental
Bloating
40% reduction
Diarrhea
82% reduction
Constipation
50% reduction
Abdominal Pain
41% reduction
Brain Fog
68% reduction
Fatigue
34% reduction
Flatulence (Gas)
34% reduction
Bathroom Urgency
38% reduction
Distension
37% reduction
Discomfort
39% reduction
Belching
18% reduction
Bowel Movement Duration
11% reduction

Published Research Using Elemental Diets .

Clinical Gastroenterology and Hepatology

Effect, Tolerability, and Safety of Exclusive mBIOTA Elemental Diet in Patients with Intestinal Microbial Overgrowth

Digestive Diseases and Sciences

Elemental Diet as a Therapeutic Modality: A Comprehensive Review

American College of Gastroenterology 2025

mBIOTA Elemental Diet Achieves Deep Remission in Dupilumab-Responsive EoE

Digestive Diseases & Sciences

Comparing Elemental Diet and Steroid Treatment in Crohn's Disease

Digestive Diseases & Sciences

mBIOTA Elemental Leads to Successful Outpatient Management of Partial Small Bowel Obstruction

American College of Gastroenterology 2025

mBIOTA Elemental Diet Does Not Promote Fungal Overgrowth and Reduce Candida

American College of Gastroenterology 2025

mBIOTA Elemental Diet Enables Outpatient Resolution of Partial Small Bowel Obstruction

American College of Gastroenterology 2025

Palatable mBIOTA Elemental Diet Reduces Visceral Fat Through Microbial and Hormonal Shifts

Digestive Disease Week 2025

Reduction of Methane Levels Correlates with Fecal Abundance of M. smithii

FNM 2024

Maintained Visceral and Total Body Fat Loss Following mBIOTA Elemental Diet

American College of Gastroenterology 2024

Achieving Organoleptic Acceptability with mBIOTA Elemental Formula

Digestive Disease Week 2024

Compliance, Safety, and Effect of Exclusive Palatable mBIOTA Elemental Diet in Microbial Overgrowth