CTRI/2023/07/055670招募中Unknown
A Randomized, double-blind, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Different Natural ingredients in improving Gut Health in adults with Leaky Gut- a pilot study - NI
试验速览
- 阶段
- Unknown
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female individuals with the age more than equal to 18 and less than equal to 65 years with moderate physical activity level as per International Physical Activity Questionnaire Short Form (IPAQ-SF)
- •2. Body mass index more than 18 and less than 29.9 kg per m square
- •3. Individuals with stool pH less than or equal to 5.5.
- •4. Individuals with constipation or diarrhoea as assessed by BSFS type 1, 2, 6 and 7 for at least 2 days.
- •5. Individuals with at least once per week complains of more than or equal to 3 of following gastrointestinal symptoms since last three months: dyspepsia, diarrhea, constipation, heartburn,nausea, acid reflux, bloating.
- •6. Individuals with no history of use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, naproxen, or indomethacin, for the last two weeks.
- •7. Willing to abstain from the use of antacids and proton pump inhibitor for the full length of the study
- •8. Individuals agreeing to consume four tablets (325 mg each) of aspirin twice within a 12-hour period.
- •9. Individuals with fasting blood glucose levels less than or equal to 125 mg per dL
- •10. Individuals with availability of western toilet at their homes for stool sample collection
- •11. Individuals who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
- •12. Individuals who are able to give written informed consent and are willing to participate in the study.
排除标准
- •1. Allergy to aspirin
- •2. Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin or mineral supplements
- •3. Performing high intensity exercise regularly using IPAQ- SF
- •4. Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening
- •5. Unwillingness to avoid the use of antidiarrheal or laxative medication on a regular or an as-needed basis during the full length of the study
- •6. Abnormal Thyroid Stimulating Hormone (TSH) value which is less than 0.40 or more than 4.50 µIU per mL
- •7. Individuals with uncontrolled type II DM defined as FBG more than 125 mg per dL.
- •8. Presence of uncontrolled hypertension defined as SBP more than equal to 140 mm Hg and or DBP more than equal to 90 mm Hg with or without anti-hypertensives
- •9. Individuals on high-fiber or fodmap diet
- •10. Individuals with known diagnosis of helicobacter pylori infection
- •11. Individuals with a history of surgical resection of the stomach, small intestine or large intestine.
- •12. Individuals with a history of or complications from inflammatory bowel disease (Crohns disease or ulcerative colitis) and ischemic colitis
- •13. Current smokers.
- •14. Use of another investigational product within 3 months of the screening visit
- •15. History or current impaired cardiovascular circulation or uncontrolled hypertension, diabetes, bleeding tendencies, kidney, liver or chronic respiratory diseases including asthma, or any other disease, that by the investigators discretion could interfere with the intestinal barrier function of the subject.
- •16. Individuals who used probiotics, prebiotics, antibiotics, prokinetics, laxatives, suppositories or enemas in the last 3 months
- •17. Individuals with a history of any diet-based intolerance (gluten or lactose intolerance)
- •18. Individuals with a history of or complications from malignant tumors
- •19. History of any significant neurological and psychiatric condition which may affect the participation and inference of the studys end points
- •20. Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or Nicotine dependence.
- •21. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men
- •22. Individuals who have clinically significant following illness, i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, other gastrointestinal diseases, etc
- •23. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives
- •24. Any condition that could, in the opinion of the investigator, preclude the participant’s ability to successfully and safely complete the study or that may confound study outcomes
研究者
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