Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03437876|
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis, Liver||Other: intestinal microbiota transplant||Not Applicable|
A group of 60 patients with HBV induced cirrhosis will be recruited for study, which involved a 4 times IMT with gastroduodenoscopy and the time interval is generally 2 weeks. Participants can keep taking their present treatment. All participants will be assessed at baseline, after 3 months, 6 months, 12 months from baseline in order to evaluate the possible changes in:
(1)Imaging changes: Color Doppler ultrasound of portal vein, CT/MRI, Fibroscan score of liver fibrosis and steatosis, Grading of varicosity under gastroscopy(GI); (2)Basic information and symptoms; (3)Biochemical indexes: Liver function, four items of liver fiber, lipid metabolism, blood routine, coagulation function, blood ammonia, inflammation, oxidative stress, urine routine; sugar metabolism indicators (blood glucose, glycosylated hemoglobin, insulin level and insulin resistance level).
(4) Changes of gut microbiota: The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) on baseline, 3 months, 6 months and 12 months after treatment samples to assess changes associated with IMT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||a open-label, self-control study|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Study on Intestinal Microbiota Transplantation for Hepatitis B Virus Induced Cirrhosis|
|Actual Study Start Date :||October 31, 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: patients with HBV induced cirrhosis
patients with HBV induced cirrhosis will be recruited for study, which involved a 4 times intestinal microbiota transplant and the time interval is generally 2 weeks.
Other: intestinal microbiota transplant
All participants take 4 times IMT by gastroduodenoscopy with 2-week intervals
- change of liver Fibroscan score [ Time Frame: 3 months, 6 months, 12months ]Fibroscan score of liver fibrosis and steatosis
- Symptoms [ Time Frame: 3 months, 6 months, 12months ]The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".
- Changes of gut microbiota [ Time Frame: 3 months, 6 months, 12months ]The changes of gut microbiota will be assessed by High-throughput sequencing (16S rRNA) in fecal samples from recruited patients.
- Color Doppler ultrasound of portal vein [ Time Frame: 3 months, 6 months, 12months ]Doppler ultrasonography is medical ultrasonography that employs the Doppler effect to generate imaging of the movement of tissues and body fluids (usually blood), and their relative velocity to the probe. By calculating the frequency shift of a particular sample volume, for example flow in an artery or a jet of blood flow over a heart valve, its speed and direction can be determined and visualized. Color Doppler is the presentation of the velocity by color scale. Color Doppler images are generally combined with grayscale (B-mode) images to display duplex ultrasonography images, allowing for simultaneous visualization of the anatomy of the area. This is particularly useful in cardiovascular studies (sonography of the vascular system and heart) and essential in many areas such as determining reverse blood flow in the liver vasculature in portal hypertension.
- CT [ Time Frame: 3 months, 6 months, 12months ]A CT scan, also known as computed tomography scan, makes use of computer-processed combinations of many X-ray measurements taken from different angles to produce cross-sectional (tomographic) images (virtual "slices") of specific areas of a scanned object, allowing the user to see inside the object without cutting. Other terms include computed axial tomography (CAT scan) and computer aided tomography.
- MRI [ Time Frame: 3 months, 6 months, 12months ]Hepatobiliary MR is used to detect and characterize lesions of the liver, pancreas, and bile ducts. Focal or diffuse disorders of the liver may be evaluated using diffusion-weighted, opposed-phase imaging, and dynamic contrast enhancement sequences. Extracellular contrast agents are used widely in liver MRI and newer hepatobiliary contrast agents also provide the opportunity to perform functional biliary imaging.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437876
|Contact: Meiya Chenemail@example.com|
|Contact: Yurou Xiefirstname.lastname@example.org|
|Zhongshan Hospital Affiliated to Xiamen University||Recruiting|
|Xiamen, Fujian, China, 361000|
|Contact: Meiya Chen +8618950107602 email@example.com|
|Contact: Yurou Xie +8618559620899 firstname.lastname@example.org|