Association Between Lactase Deficiency, and the Small Intestinal Microbiome in Adults.

NCT03860051 | Completed

• 1 other identifier: 1805571295
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the role of the enzyme (substance produced by the body that helps in a biochemical reaction like digestion in the body) responsible for digestion of lactose and the role of the gut bacteria (bacteria in the intestine) in producing symptoms of lactose intolerance.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• Lactase activity

  Lactase activity (µmol/min/g) will be assessed from small bowel biopsy specimens

  1 day

Secondary Outcomes (4)

• Symptom severity

  1 day

• Small intestinal mucosal microbiome

  1 day

• Maldigestion status

  1 day

• Fecal microbiome

  1 day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient ages 18-75 presenting for upper gastrointestinal endoscopy for any indication except those outlined in the exclusion criteria below at the IU GI Endoscopy Sites including: IU North Hospital, Glen Lehman Endoscopy Suite, Springmill/Beltway Surgery Center, IU Saxony, and Eskenazi Hospital will be eligible for participation. Participants should be willing and able to sign informed consent.

You may not qualify if:

• Patients with known bleeding diathesis given the need for small intestinal mucosal biopsies.
• Patients with known history of eosinophilic esophagitis, inflammatory bowel disease, chronic pancreatitis or pancreatic insufficiency, celiac disease, peptic duodenitis
• Antibiotic-use within the last 30 days
• Major abdominal surgery except appendectomy or cholecystectomy \> 6 months prior to enrollment
• Prior radiation therapy of the abdomen
• Use of tobacco products within the last 3 months
• Allergy to milk
• Currently pregnant or breast-feeding
• Patients taking anti-coagulant drugs
• Known diagnosis of disorders associated with abnormal GI motility (gastroparesis, amyloidosis, neuromuscular disease including Parkinson's disease, collagen vascular disease, chronic malnutrition, and uncontrolled thyroid disease)
• History of small intestinal bacterial overgrowth
• Active peptic ulcer disease noted at the time of endoscopy
• Recent colonoscopy bowel preparation or colonic enema in the preceding 4 weeks
• Chronic immunodeficiency or chronic infectious illness
• Currently undergoing chemotherapy

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endoscopy and Biopsy Sampling: Four post-bulbar mucosal biopsy samples will be taken using standard biopsy forceps from each patient. Two biopsy samples will be placed in a small, tightly capped plastic tube without any supporting media. Two biopsy samples will be submerged in Allprotect ® Tissue Reagent (Qiagen) for immediate stabilization of DNA, RNA, and protein and archived at -20 to -80 degrees Celsius for long-term storage for planned small bowel microbiome analyses. Fecal Microbiome: Stool samples will be collected and archived at -80 degrees Celsius for future analysis of the fecal microbiome

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrea S Shin, MD

  IU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: November 21, 2018
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)