Elemental Diet and Gut Microbiome

NCT ID: NCT05978973

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-06
• Study Completion Date: 2023-12-14

Brief Summary

he primary objective of this study is to assess changes in stool microbiome profiles in patients after an elemental diet.

Detailed Description

The gut microbiome is the collection of microbes residing inside the gastrointestinal (GI) tract. The involvement of the gut microbiome has been demonstrated in multiple diseases processes including irritable bowel syndrome, small intestinal bacterial overgrowth (SIBO), Crohn's disease, and ulcerative colitis among many other diseases. A "healthy" diverse gut microbiome is associated with a better response to infections and immunopathogenic insults.

Many factors can affect the gut microbiome including medications, age, disease states and diet. Among these factors, diet is the easiest factor that can be modified to improve the gut microbiome. However, conducting dietary trials is challenging due to the inability to fully standardize what subjects eat even with strict dietary instructions. Moreover, individual preferences/allergies, the source of dietary ingredients, freshness, and food preparation are important steps which affect the diet and are challenging to standardize among subjects in a diet trial. This has led to significant ambiguity regarding the true extent and depth of dietary modifications on gut microbiome.

Apart from vitamins and micronutrients, the three main food macronutrients in the human diet are carbohydrates, protein and fat. Upon digestion, carbohydrates are broken into monosaccharides, proteins into amino acids and fats mainly into fatty acids. Elemental diets contain all daily required vitamins, micronutrients and macronutrients. The ingredients are readily digestible (carbohydrates, amino acids and medium chain fatty acids) and are absorbed within the proximal small bowel. One main disadvantage of elemental diets such as Vivonex is their unpalatability which has limited their use. A palatable elemental diet can be a very valuable tool to enable us to assess the effects of diet on the gut microbiome as it bypasses several confounding effects in dietary trials such as food allergies, individual digestion variability, completeness of the diet ingredients, and food preparation.

SIBO is a condition in which the gut microbiome plays an integral role and is defined by abnormal and excessive numbers of bacteria in the small bowel.4 Interest in SIBO has been fueled by the ever-increasing awareness of the human microbiome and its potential relationships to human health and disease. SIBO is a preferred condition to assess the effects of elemental diet on the gut microbiome, given the known role of the gut microbiome in SIBO. Those with SIBO experience a range of intestinal and extraintestinal symptoms including diarrhea, nausea, bloating, abdominal pain, and excess gas.

Commonly, SIBO has been defined by two methods: direct culture of small bowel aspirates, and indirect assessment using carbohydrate (e.g. lactulose or glucose) breath testing. SIBO is generally treated with antibiotics. Low fermentable and elemental diets also have positive effects in SIBO. Based on the potential effects of diet on the gut microbiome, we hypothesize that a two-week period of an elemental diet can change the gut microbiome in SIBO subjects.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

elemental diet

subjects will be using the elemental diet packets daily. Subjects who are positive for excessive methane (i.e. methane level\>10 ppm) will be required to complete a single daily fasting methane measurement (SMM) for the duration of the 14 days.

Group Type: EXPERIMENTAL

Elemental Diet

Intervention Type: DIETARY_SUPPLEMENT

. Elemental diets contain all daily required vitamins, micronutrients and macronutrients. The ingredients are readily digestible (carbohydrates, amino acids and medium chain fatty acids) and are absorbed within the proximal small bowel. One main disadvantage of elemental diets such as Vivonex is their unpalatability3 which has limited their use.

Interventions

Elemental Diet

. Elemental diets contain all daily required vitamins, micronutrients and macronutrients. The ingredients are readily digestible (carbohydrates, amino acids and medium chain fatty acids) and are absorbed within the proximal small bowel. One main disadvantage of elemental diets such as Vivonex is their unpalatability3 which has limited their use.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• • Participant must be able to understand and provide informed consent

• Males and Females ≥18-85
• Female subjects of childbearing potential must have a negative pregnancy test upon study entry
• Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study
• Subject self-reports experiencing SIBO symptoms within 30 days
• Positive (abnormal) lactulose breath test for SIBO on visit 1 (day -7) as defined as:

• Rise of hydrogen ≥ 20ppm within 90 minutes on LBT OR
• A methane level ≥10 ppm at any point during the 120-minute LBT

Exclusion Criteria

• • Inability or unwillingness of a participant to give written informed consent or comply with study protocol

• Pregnancy or lactating
• Type 1 or type 2 diabetes
• Active or ongoing infection that requires antibiotics other than the participants known prophylactic medications (i.e. active infection or antibiotic use in the last 1 month)
• Any condition that, in the opinion of the investigator, contraindicates participation in this study will be excluded from study participation.
• History of known Phenylketonuria (PKU) disease
• Non-English-speaking participants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bianca Chang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bianca Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

References

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Other Identifiers

STUDY00002455:

Identifier Type: -

Identifier Source: org_study_id