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

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

Interventions

DIETARY_SUPPLEMENT

Diet

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.

OTHER

FMT

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.

OTHER

Physical Activity

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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-15

Primary Completion

2021-09-30

Completion

2021-09-30

Countries

• India

Study Locations