An observational study in Small Intestinal Bacterial Overgrowth, Elderly and Male, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to male participants aged 65 Years to 98 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Chinese PLA General Hospital · Observational
We will focus on the intestinal flora structure, risk factors and clinical features of male elderly with SIBO in our study.
Our previous study had found that the prevalence rate of small intestinal bacterial overgrowth(SIBO) in male elderly was high up to 63.1%. In the recent years, SIBO has been found be associated not only with abdominal symptoms such as abdominal distention, pain and so on, but also with various diseases such as diabetes, Alzheimer's disease, joint pain, chronic prostatitis, fatty liver, liver cirrhosis etc. SIBO has significant impact on the health of elderly. Methane and hydrogen lactulose breath test(LBT) is effective and noninvasive for the diagnosis of SIBO. High throughput sequencing is a leading technique for the study of intestinal microflora.
Although more and more studies have focused their concern on the intestinal flora now, few SIBO-related studies are available in elderly patients. But we have found SIBO was very popular in the elderly. The conflict between high prevalence rate of SIBO in elderly and very few relevant studies is barrier to study of pathophysiology, early diagnosis and treatment of SIBO in elderly adults.
So in our study, we will apply LBT and high throughput sequencing technique to study the intestinal flora structure, risk factors and clinical features of male elderly patients with SIBO. And further, we will try to develop standard treatment for elderly patients with SIBO.
Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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male elderly outpatients at Department of Gastroenterology, Nanlou Division, Chinese PLA General Hospita, Beijing, China
Exclusion Criteria:
male elderly who was diagnosed as SIBO via 'lactulose breath test' (LBT). At the same time, they meet the following criteria: 1. no use of antibiotics in the past 1 month. 2. no use of prokinetic drugs and probiotics in the past 1 week. 3. without these diseases: active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease.
Other: SIBO
male elderly without SIBO after 'lactulose breath test'. At the same time, they meet the following criteria: 1. no use of antibiotics in the past 1 month. 2. no use of prokinetic drugs and probiotics in the past 1 week. 3. without these diseases: active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease.
SIBO: Small intestinal bacterial overgrowth, refers to a bacterial overgrowth due to organic or functional stasis in small intestine, leading to the change in number or types of bacteria in small intestine.
amplicon sequencing of intestinal microflora
We will collect specimen(include feces and intestinal biopsy), then amplicon sequencing of intestinal microflora in specimen. And study the difference in intestinal microflora structure bwteen male elderly with and without SIBO.
Time frame: 1 year
Plan to share: No — the data of these male elederly enrolled in the study are secret on account of their status
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Chinese PLA General Hospital