A trial to assess the use of Efficacy of Stool Transplantation in patients suffering from Chronic Hepatitis B.

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.HBsAg positive and HBeAg positive at the time of screening.

2.ALT levels â?? normal or any level greater than upper normal limit (ULN)

3.DNA- any

4.Treated with nucleoside/nucleotide analogues for atleast a year.

5.Willing and able to comply with the FMT regimen and all other study requirements.

6.The patient or guardian is willing and able to provide written informed consent to participate in the study.

Exclusion Criteria

1.Pregnant or breastfeeding. Women of child bearing potential will be screened with beta human chorionic gonadotropin (ï?¢-HCG).

2.Co-infection with hepatitis C virus (HCV) and Human Immunodeficiency Virus I and II (HIV).

3.Medical conditions that require prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc). Prolonged use means episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.

4.History of acute decompensation defined as presence of jaundice, ascites, variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.

5.Patients with hepatocellular carcinoma (HCC).

6.Liver disease due to other etiologies.

7.Patient with daily alcohol consumption of more than 30 gm of ethanol or abusing illicit drugs.

8.Frequent or prolonged use of systemic corticosteroids (e.g., severe asthma, severe arthritis or autoimmune conditions, organ transplantation, adrenal insufficiency, etc).

9.Medical conditions requiring the use of potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, anti-tuberculosis regimens, others) or nephrotoxic drugs (e.g., frequent NSAIDs, aminoglycosides, amphotericin B, foscarnet).

10.Patients on warfarin or other anticoagulants during 30 days prior to screening or if expected during the present study.

11.Other concurrent medical conditions likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study (e.g., concurrent malignancies, history of unstable angina, repeated myocardial infarction or congestive heart failure, renal insufficiency, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)To assess the efficacy of fecal microbial transplantation in HBeAg seroconversion in patients with chronic HBV (HBeAg positive) infection on oral nucleos(t)ide analogues for atleast 1 year.Timepoint: 1, 2, 3, 4,5, 6, 9 ans 12 months

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the change in serum HBsAg (quantitative) at 1, 2, 3, 4, 5, 6, 9 and 12 months of therapy. <br/ ><br>2.To evaluate durability of response at 6 months after completion of FMT. <br/ ><br>3.Safety assessment, including incidence of clinical adverse events and incidence of laboratory abnormality after FMT. <br/ ><br>4.ALT normalization at 1, 3, 6, 9 and 12 months, in patients with raised levels at baseline. <br/ ><br>5.Change in HBV DNA level from baseline at 1, 2, 3, 4 5, 6, 9, and 12 months of FMT therapy. <br/ ><br>Timepoint: 1,2,3,4,5,6,9 and 12 months