Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 55
- 主要终点
- Composite EED (Environmental Enteric Dysfunction) Histopathologic Score
研究概览
简要总结
The goal of this clinical trial is to learn whether teduglutide, a medicine that helps the intestine heal, can improve environmental enteric dysfunction in undernourished women aged 18 to 35 years living in urban slums of Dhaka.
Environmental enteric dysfunction is a long-lasting condition of the small intestine. It causes inflammation and poor absorption of nutrients. Many people with this condition do not have clear symptoms, but it can make undernutrition worse. At present, there is no proven treatment for this condition.
The main questions this study aims to answer are:
- Does taking teduglutide for 30 days improve damage to the small intestine, as seen on intestinal biopsy?
- Does teduglutide improve blood and stool markers related to gut inflammation and nutrient absorption?
Participants will:
- Receive nutritional support at the start of the study
- Undergo an upper gastrointestinal endoscopy to confirm environmental enteric dysfunction
- Receive a daily injection of teduglutide under the skin for 30 days
- Undergo repeat endoscopy and laboratory tests after treatment to assess changes in gut health The results of this study will help researchers understand whether teduglutide may be a useful treatment for environmental enteric dysfunction in undernourished adult women and will guide future, larger studies.
详细描述
Background:
Burden: Recent studies indicated an association between undernutrition and Environmental Enteric Dysfunction (EED) with more than 90% of undernourished women in Dhaka slum having histo-pathological evidence of EED.
Knowledge gap: Currently, there is no available treatment for this condition. Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, has been shown to improve damaged intestinal mucosa, improve villi height, absorptive capacity, and reduce mucosal inflammation. A recent study among children in Zambia and Zimbabwe with malnutrition enteropathy demonstrated significant improvement of EED features with no adverse effect following teduglutide treatment.
Relevance: Given the fundamental structural and functional alterations of the intestine due to EED, GLP-2 analogues such as teduglutide could significantly revolutionize treatment strategies. However, teduglutide has not yet been trialed in adults with EED.
Hypothesis: Daily treatment Glucagon-like Peptide 2 (GLP-2) Analog teduglutide for thirty days will improve histologic and biomarkers features of EED in undernourished women with biopsy-proven EED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Bangladeshi women, aged 18-35 years
- •BMI between 16 kg/m2 to 18.5 kg/m2
- •No antibiotics for 1 month
- •Willing to sign the consent form
- •Willing to receive food and multiple micronutrient supplementation for 2 months
- •Willing to receive daily one-month sub-cutaneous GLP 2 analog, Teduglutide treatment
- •Willing to undergo endoscopy and biopsy, twice, before and after intervention, if failed to respond to nutrition intervention and who did not have other chronic or acute diseases that may cause malnutrition
- •Willing to provide biological samples during the study period of 4 months
排除标准
- •Severe anemia (<8 g/dl), known case of TB, and other chronic diseases, including diabetes mellitus or any congenital disorder or deformity
- •Pregnancy, lactation, drug abuse, known psychiatric disorders
- •High clinical suspicion of cancer or other chronic or acute diseases that may cause malnutrition.
- •Known allergy to any components of nutrition intervention or any GI polyp
- •Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days
研究组 & 干预措施
Teduglutide Treatment Arm
Sub-cutaneous Teduglutide treatment (0.05 mg/kg/day)
干预措施: Teduglutide 0.05 dose (Drug)
结局指标
主要结局
Composite EED (Environmental Enteric Dysfunction) Histopathologic Score
时间窗: Baseline and 30 days after teduglutide treatment
The primary outcome is the EED score, a continuous measure derived from histomorphological features of the intestinal mucosa obtained through upper gastrointestinal endoscopy (EGD) with mucosal biopsy. The score ranges from 0 to 7, with higher scores indicating more severe intestinal damage. The score will be calculated before treatment and after 30 days of daily subcutaneous teduglutide administration to assess changes in intestinal histology.
次要结局
未报告次要终点