Effects of Fecal Microbiota Transplantation on Weight in Obese Patients With Non-alcoholic Fatty Liver Disease

NCT04594954 | Unknown

• 1 other identifier: ILBS-FMT-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The worldwide impact of obesity suggests an urgent need for solutions to decrease its burden on modern society. It has been generally understood that obesity is caused by a simple imbalance in the intake of energy in the form of food compared with the expenditure of energy by the body the human microbiota consists of a wide variety of microorganisms, including bacteria, archaea, fungi, viruses, protozoans and yeast. These organisms colonize both the exterior and interior of the human body in numbers that are equivalent to those of human cells of their host. Current research has identified numerous physiological and psycho-modulatory functions of the gut microbiota, including digesting food, stimulating cell growth, strengthening the immune system, preventing allergies and diseases, and impacting emotion. The gut microbiota can contribute to host physiology through metabolite production, such as short-chain fatty acids (SCFAs), which can modulate the intestinal barrier and inflammation 9.Dysbiosis of the gut microbiota, defined as a decrease in commensal bacteria levels and diversity, has been linked to diseases such as stomach/colon/liver cancer 2, obesity 9,inflammatory bowel disease (IBD) and anxiety.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving ≤ 5%of the weight loss in kg from baseline

  3 months

Secondary Outcomes (51)

• Proportion of patients achieving ≤ 5% of the weight loss in kg from baseline

  6 months

• Proportion of patients achieving ≤ 5% of the weight loss in kg from baseline

  12 months

• Changes in waist circumference and waist hip ratio

  3 months

• Changes in waist circumference and waist hip ratio

  6 months

• Changes in waist circumference and waist hip ratio

  1 year

Study Arms (2)

Diet + Exercise + FMT

EXPERIMENTAL

Dietary Supplement: Diet; Other: FMT; Other: Physical Activity

Diet+Exercise

ACTIVE COMPARATOR

Dietary Supplement: Diet; Other: Physical Activity

Interventions

Diet DIETARY_SUPPLEMENT

A high-protein low carbohydrate diet (HPLC) diet would be prescribed to the patients. HPLC (high-protein low carbohydrate) diet would comprise of energy as 20-25 Kcal/Kg IBW/day (amounting to 700- 800 Kcal less than the usual dietary intake), Protein as 1.2-1.5 gm/Kg IBW/day i.e. 30% of the total calories as proteins, 52% of carbohydrates 18% of fats with dietary fiber as 25 g/day. The protein requirements would be met with modular high protein, low calorie supplements.

Diet + Exercise + FMT; Diet+Exercise

FMT OTHER

Stool Administration Procedure (ILBS FMT Protocol) * 500 mL filtrates will be delivered through the UGI Endoscopy into proximal jejunum \[(2 to 3 minutes per 50 ml).\] * The recipient will be kept nil per oral for at least 4 hours prior to the stool instillation. * 100 mL freshly thawed sample will be given once in 15 days for 3 doses * Non-absorbable antibiotics will be avoided in the patient from the time of enrollment into the study and therapy initiation. * Intravenous antibiotics will be continued as per institutional protocol in the event of active sepsis based on culture and sensitivity. * The patient will be allowed to consume liquid diet two hours after the procedure.

Diet + Exercise + FMT

Physical Activity OTHER

Physical Activity: The exercise program would consist of brisk walking. Brisk walking is defined as the walking intensity of 60-70% of their respective age-predicted maximum heart rate (target heart rate) 27,28. Speed of 5- 6 kmph considered as a brisk walking in most of the studies preferably on a treadmill for a duration of 30-45 minutes30 or brisk walking (walking faster than normal pace, measure 5000 steps continuously by pedometer). Same amount of physical activity would be prescribed to both the groups for 5 days a week for 30 -45 min.

Diet + Exercise + FMT; Diet+Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients posted for Upper GI endoscopy for other indications
• yrs of age with NAFLD and
• BMI ≤ 35 or
• Body Mass Index (BMI) is ≤30 to 34.9 kg/m2 with at least one treated or untreated comorbid condition (hypertension, dyslipidaemia, cardiovascular disease, glucose intolerance, sleep apnoea, NASH).
• Ambulatory and able to perform the ILBS healthy lifestyle (diet and exercise program).
• Failed to life style therapy.

You may not qualify if:

• HIV, HBsAg or HCV positive
• Prior bariatric surgery
• Change in weight of ≤5 % within 3 months
• Malignancy within 5 years
• Recent major surgery; history of seizure disorder
• Depression or other major psychiatric disease within 2 years requiring treatment with prescription medication
• Pregnancy or lactation
• Significant uncontrolled cardiopulmonary diseases
• Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening
• Hypo or hyperthyroidism uncontrolled. If initiation or adjustment of doses of these drugs is anticipated, patients should not be enrolled.
• Patients being treated for hypothyroidism must be adequately replaced on a stable dose of medication for at least 3 months prior to screening.
• Uncontrolled DM with HbA1c greater than 9%.
• Recent treatment (i.e., within 1 month of the screening visit) with weight drugs or products or appetite suppressants (including herbal weight agents)
• Recent treatment (i.e., within 3 months of the screening visit) with oral or parenteral corticosteroids
• Recent history (within 2 years prior to the screening visit) of significant alcohol use

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dr Pinakee Sunder Kar, MD

CONTACT

01146300000; pinakeesunder@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 20, 2020
• Study Start: October 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

IN (1)