Elemental Diet and Gut Microbiome

NCT05978973 | Completed

• 1 other identifier: STUDY00002455:
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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).

  28 DAYS

Study Arms (1)

elemental diet

EXPERIMENTAL

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.

Dietary Supplement: Elemental Diet

Interventions

Elemental Diet 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.

elemental diet

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (10)

• 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.

  PMID: 35288511 BACKGROUND

• 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.

  PMID: 34933047 BACKGROUND

• Moore DA, Schatz D. Overprecision increases subsequent surprise. PLoS One. 2020 Jul 8;15(7):e0227084. doi: 10.1371/journal.pone.0227084. eCollection 2020.

  PMID: 32639957 BACKGROUND

• 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.

  PMID: 26818834 BACKGROUND

• Rubin R. Botulinum Toxin to Treat Endometriosis Pain. JAMA. 2019 Aug 27;322(8):716. doi: 10.1001/jama.2019.12350. No abstract available.

  PMID: 31454029 BACKGROUND

• 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.

  PMID: 28272402 BACKGROUND

• 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.

  PMID: 14992438 BACKGROUND

• 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.

  PMID: 32088068 BACKGROUND

• 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.

  PMID: 31660965 BACKGROUND

• Rezaie A, Chang BW, de Freitas Germano J, Leite G, Mathur R, Houser K, Hosseini A, Brimberry D, Rashid M, Mehravar S, Villanueva-Millan MJ, Sanchez M, Weitsman S, Fajardo CM, Rivera IG, Joo L, Chan Y, Barlow GM, Pimentel M. Effect, Tolerability, and Safety of Exclusive Palatable Elemental Diet in Patients With Intestinal Microbial Overgrowth. Clin Gastroenterol Hepatol. 2025 Nov;23(12):2306-2317.e7. doi: 10.1016/j.cgh.2025.03.002. Epub 2025 Apr 4.

  PMID: 40189034 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bianca Chang, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: August 6, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)