Fecal microbiota capsule, as well as preparation method and application thereof

A fecal bacteria and capsule technology, which is applied to the fecal bacteria capsules and the fields of preparation and application thereof, can solve the problems of short storage time, limitation, inconvenient access, etc., and achieve the effects of increasing safety and improving freeze-drying survival rate.

Active Publication Date: 2015-09-23
THE THIRD AFFILIATED HOSPITAL OF THIRD MILITARY MEDICAL UNIV OF PLA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Modern fecal bacteria transplantation technology is mainly the method of instrument intervention, such as gastroscopy, gastric tube, colonoscopy, jejunal tube, etc. The treatment of diarrhea-type IBS and ulcerative colitis requires multiple transplants, and each time the fecal flora needs to pass through the catheter After passing through the stomach and duodenum, it is injected into the distal end of the duodenum. The process is complicated, the patient has certain pain, and the application is limited.
The prepared fecal bacteria samples are stored at room temperature for a short time and need to be transplanted immediately. Although they can be frozen at -80°C after adding sterile glycerin, it is inconvenient to take

Method used

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  • Fecal microbiota capsule, as well as preparation method and application thereof
  • Fecal microbiota capsule, as well as preparation method and application thereof
  • Fecal microbiota capsule, as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] To prepare fecal bacteria capsules:

[0065] Method 1: Put about 120 g of fresh feces samples from the donor in a blender, add 250 ml of sterile 0.9% NaCl solution for preliminary homogenization; filter the fecal slurry through a stainless steel filter to remove large particles; put it on ice Transported to the laboratory and processed within 2 hours after collection; samples were weighed in a nitrogen bioengineering kitchen and further homogenized in a homogenizer. The slurry was filtered step by step through molecular sieves with diameters of 2.0mm, 1.0mm, 0.4mm and 0.1mm to remove unabsorbed food residues and small particulate matter; the re-filtered samples were centrifuged at 3000 rpm for 10min, and the sediment Resuspend in 100ml of 0.9% NaCl solution, disperse and resuspend. Drop from 25°C to -80°C through the "two-step method": the first step is to cool down at a rate of 1-2°C / min; the second step is to cool down at a rate of 3-5°C / min; the total pre-freezing t...

Embodiment 2

[0079] The fecal bacteria capsule prepared by embodiment 1 method 3~5 is carried out clinical trial:

[0080] Requirements for donors:

[0081] 1) Obtain the informed consent of the fecal donor and recipient before FMT.

[0082]2) Donors are mainly selected from individuals who have a close relationship with the recipient, such as husband and wife, parents, children and close friends. This is related to the willingness of the recipients. At the same time, this part of the population has a similar micro-ecological environment to the recipients, which may theoretically have a more positive effect on FMT. Gough et al. believed that the use of feces from relatives or friends of recipients was more effective than feces from unrelated donors, and pointed out that gender differences between donors and recipients had little effect on disease remission.

[0083] 3) Donor inclusion criteria:

[0084] ①No known infectious diseases;

[0085] ② No antibacterial drugs or other drugs tha...

Embodiment 1

[0117] Embodiment 1 method 3~5.

[0118] 4. Standardized program for transplantation:

[0119] ①Recipients stopped using antibacterial drugs 3 days before transplantation;

[0120] ②Recipients, regardless of the transplantation route, should prepare for intestinal cleansing 1 day before;

[0121] ③Give metoclopramide, an anti-motor function drug, to facilitate intestinal retention of fecal fluid;

[0122] ④ Proton pump inhibitors should be given the night before and in the morning of FMT to inhibit the secretion of gastric acid.

[0123] ⑤ Within 2 days after transplantation, closely observe the patient's abdominal pain and diarrhea, and observe the patient's body temperature. If there are transient adverse reactions, such as elevated body temperature and transient increase in the number of diarrhea, symptomatic treatment should be taken.

[0124] 5. Standardized capsule resuscitation and administration process

[0125] ①A total of 12 capsules, given in two days, 6 capsule...

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Abstract

The invention belongs to the technical field of fecal microbiota transplantation, and particularly relates to a fecal microbiota capsule, as well as a preparation method and application of the fecal microbiota capsule. The preparation method comprises the following steps: (1) a fecal microbiota solution is prepared; (2) the fecal microbiota solution, obtained in the step (1), is added with a freeze-drying protective additive, and freeze drying is performed to obtain fecal microbiota freeze-dried powder; (3) a capsule is filled with the fecal microbiota freeze-dried powder, obtained in the step (2), to obtain the fecal microbiota capsule. Through adoption of the fecal microbiota capsule, flora is enabled to be comparatively concentrated and can be preserved for a long time at a low temperature; implementation of flora transplantation is facilitated, and invasive implementation manners, such as a gastroscope, an enteroscope and a nasointestinal feeding tube, are not needed; when the fecal microbiota capsule is applied to weak patients, the safety is increased.

Description

technical field [0001] The invention belongs to the technical field of fecal bacteria transplantation, and in particular relates to a fecal bacteria capsule and its preparation and application. Background technique [0002] Fecal microbiota transplantation (FMT), also known as fecal microbiota therapy or intestinal microbiota transplantation, is to transplant the functional flora in the feces of healthy people into the gastrointestinal tract of patients to rebuild the intestinal flora with normal functions and achieve intestinal Diagnosis and treatment of intestinal and extraintestinal diseases. At present, fecal microbiota transplantation has been regarded as a special organ transplantation for the treatment of Clostridium difficile infection, inflammatory bowel disease, irritable bowel syndrome, metabolic syndrome, neurodevelopmental dysplasia and neurodegenerative diseases , autoimmune enteropathy, intestinal food allergy, etc. Fecal transplants have been used in China ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/745A61K35/744A61K35/741A61K9/48A61K47/04A61P1/00A61P29/00
Inventor 魏艳玲陈东风
Owner THE THIRD AFFILIATED HOSPITAL OF THIRD MILITARY MEDICAL UNIV OF PLA
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