search
Back to results

Elemental Diet and Gut Microbiome

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elemental Diet
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

elemental diet

Arm Description

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.

Outcomes

Primary Outcome Measures

assess changes in stool microbiome profiles
is to assess changes in stool microbiome profiles in patients after an elemental diet, as determined by 16S rRNA gene sequencing • Microbiome profiles will be determined in stool samples provided on visit 2 (day 0), visit 4 (day 14) and visit 6 (day 28). These analyses will be performed in batch at the end of the study and the profiles at visit 4 (day 14) and visit 6 (day 28) will be compared to those at visit 2 (day 0).

Secondary Outcome Measures

Full Information

First Posted
July 30, 2023
Last Updated
August 8, 2023
Sponsor
Cedars-Sinai Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05978973
Brief Title
Elemental Diet and Gut Microbiome
Official Title
Elemental Diet and Gut Microbiome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
elemental diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Elemental Diet
Intervention Description
. 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.
Primary Outcome Measure Information:
Title
assess changes in stool microbiome profiles
Description
is to assess changes in stool microbiome profiles in patients after an elemental diet, as determined by 16S rRNA gene sequencing • Microbiome profiles will be determined in stool samples provided on visit 2 (day 0), visit 4 (day 14) and visit 6 (day 28). These analyses will be performed in batch at the end of the study and the profiles at visit 4 (day 14) and visit 6 (day 28) will be compared to those at visit 2 (day 0).
Time Frame
28 DAYS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MAST Program
Phone
(310) 423-0617
Email
mastprogram@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad Rashid
Phone
(310) 423-0617
Email
mastprogram@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bianca Chang, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35288511
Citation
Pimentel M, Mathur R, Wang J, Chang C, Hosseini A, Fiorentino A, Rashid M, Pichetshote N, Basseri B, Treyzon L, Chang B, Leite G, Morales W, Weitsman S, Kraus A, Rezaie A. A Smartphone Application Using Artificial Intelligence Is Superior To Subject Self-Reporting When Assessing Stool Form. Am J Gastroenterol. 2022 Jul 1;117(7):1118-1124. doi: 10.14309/ajg.0000000000001723. Epub 2022 Mar 14.
Results Reference
background
PubMed Identifier
34933047
Citation
Wu X, Zhu Y, Yang M, Zhang J, Lin D. Biological responses of Eisenia fetida towards the exposure and metabolism of tris (2-butoxyethyl) phosphate. Sci Total Environ. 2022 Mar 10;811:152285. doi: 10.1016/j.scitotenv.2021.152285. Epub 2021 Dec 18.
Results Reference
background
PubMed Identifier
32639957
Citation
Moore DA, Schatz D. Overprecision increases subsequent surprise. PLoS One. 2020 Jul 8;15(7):e0227084. doi: 10.1371/journal.pone.0227084. eCollection 2020.
Results Reference
background
PubMed Identifier
26818834
Citation
Kilic E, Tennstedt P, Hogner A, Lebok P, Sauter G, Bokemeyer C, Izbicki JR, Wilczak W. The zinc-finger transcription factor SALL4 is frequently expressed in human cancers: association with clinical outcome in squamous cell carcinoma but not in adenocarcinoma of the esophagus. Virchows Arch. 2016 Apr;468(4):483-92. doi: 10.1007/s00428-016-1908-y. Epub 2016 Jan 27.
Results Reference
background
PubMed Identifier
31454029
Citation
Rubin R. Botulinum Toxin to Treat Endometriosis Pain. JAMA. 2019 Aug 27;322(8):716. doi: 10.1001/jama.2019.12350. No abstract available.
Results Reference
background
PubMed Identifier
28272402
Citation
Rotovnik Kozjek N, Kompan L, Zagar T, Mrevlje Z. Influence of enteral glutamine on inflammatory and hormonal response in patients with rectal cancer during preoperative radiochemotherapy. Eur J Clin Nutr. 2017 May;71(5):671-673. doi: 10.1038/ejcn.2017.11. Epub 2017 Mar 8.
Results Reference
background
PubMed Identifier
14992438
Citation
Pimentel M, Constantino T, Kong Y, Bajwa M, Rezaei A, Park S. A 14-day elemental diet is highly effective in normalizing the lactulose breath test. Dig Dis Sci. 2004 Jan;49(1):73-7. doi: 10.1023/b:ddas.0000011605.43979.e1.
Results Reference
background
PubMed Identifier
32088068
Citation
Gombert A, Van Herzeele I. We Want to OPERATE! Eur J Vasc Endovasc Surg. 2020 May;59(5):775. doi: 10.1016/j.ejvs.2020.01.033. Epub 2020 Feb 20. No abstract available.
Results Reference
background
PubMed Identifier
31660965
Citation
Speller B, Metcalfe K, Kennedy ED, Facey M, Greenblatt E, Scheer AS, Warner E, Joy AA, Wright FC, Baxter NN. The "Begin Exploring Fertility Options, Risks and Expectations" (BEFORE) decision aid: development and alpha testing of a fertility tool for premenopausal breast cancer patients. BMC Med Inform Decis Mak. 2019 Oct 28;19(1):203. doi: 10.1186/s12911-019-0912-y.
Results Reference
background

Learn more about this trial

Elemental Diet and Gut Microbiome

We'll reach out to this number within 24 hrs