Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-07

Study Completion Date

2025-06-30

Brief Summary

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This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.

The aims of the study are:

To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.

To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.

To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement.

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Detailed Description

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Conditions

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Hepatic Encephalopathy Dysbiosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fecal microbiota transplantation through colonoscopy and oral capsules

Patients with cirrhosis and hepatic encephalopathy refractory to conventional treatment will undergo a two-stage fecal microbiota transplantation: initial colonoscopic delivery followed by daily oral capsules administration one month later. Patients will continue also conventional therapy with rifaximin and lactulose

Group Type EXPERIMENTAL

Fecal microbiota transplantation delivery through colonoscopy

Intervention Type PROCEDURE

Patients will receive 4 L of macrogol and salts solution the afternoon before FMT and remain fasting the night before the scheduled treatment. During colonoscopy, about 350 mL of donor fecal preparation will be infused in the cecum.

Fecal microbiota transplantation delivery through oral capsules

Intervention Type DRUG

Intestinal gastro-resistant capsules (capacity 0.91 mL, overall 10\^8-9 bacteria per capsule) will be filled with the fecal slurry. From each donation weighing 100 g, it is expected to obtain 150 cps, which will be promptly frozen and stored at -80°C. At each monthly visit, the patient will receive 60 capsules, to be stored at -20°C at home. Capsules will be administered orally at the dose of 1 cps twice a day from month 1 post-colonoscopy to patients in the FMT group 1 (colonoscopy plus capsules), and from day 1 to patients in the FMT group 2 (capsules only).

Fecal microbiota transplantation through oral capsules

Patients with cirrhosis and hepatic encephalopathy refractory to conventional treatment will undergo fecal microbiota transplantation through daily oral capsules administration. Patients will continue also conventional therapy with rifaximin and lactulose.

Group Type EXPERIMENTAL

Fecal microbiota transplantation delivery through oral capsules

Intervention Type DRUG

Intestinal gastro-resistant capsules (capacity 0.91 mL, overall 10\^8-9 bacteria per capsule) will be filled with the fecal slurry. From each donation weighing 100 g, it is expected to obtain 150 cps, which will be promptly frozen and stored at -80°C. At each monthly visit, the patient will receive 60 capsules, to be stored at -20°C at home. Capsules will be administered orally at the dose of 1 cps twice a day from month 1 post-colonoscopy to patients in the FMT group 1 (colonoscopy plus capsules), and from day 1 to patients in the FMT group 2 (capsules only).

Controls

Patients with cirrhosis and hepatic encephalopathy refractory to conventional treatment will continue only conventional therapy with rifaximin and lactulose

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fecal microbiota transplantation delivery through colonoscopy

Patients will receive 4 L of macrogol and salts solution the afternoon before FMT and remain fasting the night before the scheduled treatment. During colonoscopy, about 350 mL of donor fecal preparation will be infused in the cecum.

Intervention Type PROCEDURE

Fecal microbiota transplantation delivery through oral capsules

Intestinal gastro-resistant capsules (capacity 0.91 mL, overall 10\^8-9 bacteria per capsule) will be filled with the fecal slurry. From each donation weighing 100 g, it is expected to obtain 150 cps, which will be promptly frozen and stored at -80°C. At each monthly visit, the patient will receive 60 capsules, to be stored at -20°C at home. Capsules will be administered orally at the dose of 1 cps twice a day from month 1 post-colonoscopy to patients in the FMT group 1 (colonoscopy plus capsules), and from day 1 to patients in the FMT group 2 (capsules only).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of liver cirrhosis
* Hepatic encephalopathy of grade \>1 or higher according to West Haven classification, persistent or recurrent despite treatment with lactulose/lactitol and rifaximin at adequate doses started at least 30 days before the Hepatic encephalopathy episode

Exclusion Criteria

* Na \<130 meq /l
* Creatinine \> 1.3 mg / dl
* Presence of grade 3 ascites
* Presence of esophagogastric varices at risk of haemorrhage in the absence of adequate prophylaxis
* Presence of other possible causes of encephalopathy (cerebral vascular disease, known neurodegenerative or cognitive disorders)
* Known psychiatric disorders or other causes of brain dysfunction (e.g. hypoglycemia, hyponatremia)
* Alcohol consumption
* Diagnosis of hepatocellular carcinoma
* Contraindication to fecal microbiota transplantation (e.g. pregnancy or breastfeeding)
* Presence of known intestinal diseases
* Any clinical condition that, in the opinion of the investigators, may contraindicate the enrollment in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No