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American Focus > Blog > Health and Wellness > Clinical trial finds novel nutritional formula effectively treats gut microbial overgrowth
Health and Wellness

Clinical trial finds novel nutritional formula effectively treats gut microbial overgrowth

Last updated: April 22, 2025 7:49 pm
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Clinical trial finds novel nutritional formula effectively treats gut microbial overgrowth
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In a groundbreaking study published in Clinical Gastroenterology and Hepatology, Cedars-Sinai researchers have introduced a novel nutritional formula called mBiota Elemental, a palatable elemental diet (PED) that has shown promising results in treating patients with small intestinal bacterial overgrowth (SIBO) and intestinal methanogen overgrowth (IMO).

The mBiota Elemental diet is a highly digestible nutritional formula designed to provide complete nutrition with minimal stimulation of the digestive system. It contains free amino acids, simple carbohydrates, minimal fat, and essential micronutrients. Elemental diets have traditionally been used in conditions such as Crohn’s disease, eosinophilic esophagitis/gastroenteritis, and chronic pancreatitis.

Patients with SIBO and IMO have abnormally high levels of coliform bacteria or methanogenic archaea in their gastrointestinal tract. While antibiotics have been the primary treatment for these conditions, recurrence is common and can have negative effects on the overall microbiome. The use of elemental diets to reduce microbial overgrowth has shown promise in previous studies, but poor palatability has limited their effectiveness.

The study involved 30 adult participants with confirmed diagnoses of SIBO, IMO, or both. All participants underwent a two-week trial of the mBiota Elemental PED, followed by a two-week period of regular food reintroduction. The results were promising, with 73% of participants experiencing normalization of breath tests and 83% reporting adequate relief of symptoms.

Significant reductions in exhaled methane and hydrogen levels were observed, along with changes in the gut microbiome composition. Symptoms such as bloating, distention, abdominal discomfort, constipation, and flatulence improved during the PED phase, while additional symptoms improved during the food reintroduction phase.

The mBiota Elemental diet was well-tolerated, with no serious adverse events reported. Mild side effects included diarrhea, cramps, nausea, fatigue, and heartburn. The formula’s improved taste, smell, and texture were credited for the high adherence rate among participants.

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Overall, the study suggests that a short-term course of the mBiota Elemental diet may offer an effective non-antibiotic dietary approach for managing SIBO and IMO. Further controlled trials are needed to evaluate long-term outcomes and mechanisms underlying the diet’s effectiveness.

The findings of this study hold promise for patients with microbial overgrowth syndromes, offering a potentially more palatable and tolerable treatment option compared to traditional antibiotic therapies. Further research will be crucial in expanding our understanding of the role of elemental diets in managing gastrointestinal conditions.

TAGGED:clinicalEffectivelyfindsFormulagutmicrobialnutritionalovergrowthtreatsTrial
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