A Randomized Controlled Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients having on average three or more SCBMs/week
研究概览
简要总结
The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.
详细描述
Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Constipation frequency appears to augment with increasing age, particularly after 65 years old.
Recent evidence in the literature and collected in the investigators' laboratory confirm that constipation can be a consequence of intestinal dysbiosis, with an increase of potentially pathogenic microorganisms and a decrease of potentially beneficial microorganisms. These alterations may affect the motility and metabolic environment of colon, especially the production of short chain fatty acids (SCFAs).
A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI) and other extraintestinal conditions (e.g. IBD). Similarly, the investigators suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;
- •Age ≥ 18 years;
- •BMI: 18.5-25 kg/m2;
- •Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) > 48 hours);
- •Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
- •No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast;
- •Disease duration > 1 year;
- •Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;
排除标准
- •Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);
- •History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ;
- •Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
- •Previous proctological or perianal surgery;
- •A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
- •Pregnant or breast-feeding women;
- •Infection with enteric pathogen;
- •Usage of probiotics, prebiotics and/or synbiotics within the last month;
- •Usage of antibiotics and/or PPIs within the last 3 months;
- •Smoking or alcohol addiction within the last 3 months;
- •Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
- •Disease or therapy with drugs (i.e. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.
研究组 & 干预措施
Fecal microbiota transplantation (FMT)
On day 1-6, patients received 100ml fresh FMT by nasointestinal tube, once per day. The nasointestinal tube was placed in the patient's proximal jejunum through endoscopy. Then, donor fecal microbiota was infused within 5 minutes through nasointestinal tube.
干预措施: Fecal microbiota transplantation (FMT) (Drug)
Fecal microbiota transplantation (FMT)
On day 1-6, patients received 100ml fresh FMT by nasointestinal tube, once per day. The nasointestinal tube was placed in the patient's proximal jejunum through endoscopy. Then, donor fecal microbiota was infused within 5 minutes through nasointestinal tube.
干预措施: Conventional treatment (Behavioral)
Conventional treatment
Conventional treatment was taken by both of two groups. If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax®, Ipsen, Paris, France). If ineffective, an enema could be used.
干预措施: Fecal microbiota transplantation (FMT) (Drug)
Conventional treatment
Conventional treatment was taken by both of two groups. If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax®, Ipsen, Paris, France). If ineffective, an enema could be used.
干预措施: Conventional treatment (Behavioral)
结局指标
主要结局
Proportion of patients having on average three or more SCBMs/week
时间窗: 3 months
Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at week 4 and 12.
次要结局
- Characteristics of bowel movements(3 months)
- Mean number of bowel movements per week(3 months)
- Constipation-related symptoms assessments(3 months)
- Quality-of-Life assessments(3 months)
- Colonic transit time measurements(3 months)
- Usage of laxatives or enemas as rescue medication(3 months)
- Adverse events(3 months)
研究者
Jianfeng Gong
Associate professor
Jinling Hospital, China