Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. The study is a single-center, prospective, randomized, single-blind, controlled, cohort study. The invesitigators plan to enroll 80 patients with functional constipation and 80 patients with irritable bowel syndrome. The invesitigators will randomize the included study subjects. The experimental group receive basic treatment and a single infusion of probiotics through colonoscopy. The control group receive basic treatment and a single injection of normal saline through colonoscopy. The invesitigators will follow up the patients for 8-12 weeks. The primary endpoint is the efficacy of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. The secondary endpoint is the safety of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. Other exploratory objectives include the alterations in clinical indicators, fecal microbiota, and intestinal microbiota metabolites in feces and serum.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Combined Bifidobacterium and Lactobacillus | Experimental | The experimental group receive basic treatment and a single infusion of Live Combined Bifidobacterium and Lactobacillus solution through colonoscopy. |
|
| Control | Placebo Comparator | The control group receive basic treatment and a single injection of normal saline through colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Combined Bifidobacterium and Lactobacillus | Drug | The invesitigators give patients Live Combined Bifidobacterium and Lactobacillus solution infusion during their colonoscopy examination for a single time in the Live Combined Bifidobacterium and Lactobacillus group. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of effective patients with functional constipation and irritable bowel syndrome patients | The efficacy of irritable bowel syndrome is evaluated by stool texture and abdominal discomfort related scales including IBS-SSS, BSS score, IBS-QOL,HADS and number of bowel movements per day in 12 weeks after start of treatment. The efficacy of functional constipation is evaluated by weekly defecation frequency, spontaneous complete bowel movement, and scales such as Wexner constipation score, BSS score, and PAC-QOL in 8 weeks after start of treatment. | 8-12 weeks after start of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events related to treatment | The safety of single colonoscopic probiotics infusion was evaluated by incidence of adverse events related to colonoscopic probiotics infusion during the treatment and 8-12 weeks after the treatment. | 8-12 weeks after start of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota | 16S rRNA detection of fecal intestinal flora. | 8-12 weeks after start of treatment. |
| Intestinal microbiota metabolites | Detection of gut microbiota metabolites in blood and feces by HPLC-MS/MS. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Feng, M.D. | Contact | 0086-029-85323920 | amyyun@xjtu.edu.cn | |
| Hongxia Li, M.D. | Contact | 0086-029-85323920 | hongxia1105@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yun Feng, M.D. | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C100843 | Lacteol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Normal saline | Drug | The invesitigators give patients normal saline as a placebo infusion during their colonoscopy examination for a single time in the control group. |
|
|
| Basic treatment | Drug | The invesitigators give patients general treatment and drug treatment including oral Live Combined Bifidobacterium and Lactobacillus tablets as basic treatment. |
|
| 8-12 weeks after start of treatment. |
| D004066 | Digestive System Diseases |