High Amylose Maize Starch for Treatment of Cholera
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
- Burden: Watery diarrhea including cholera continues to be a major cause of childhood mortality in developing countries, with an estimated 1.5 million children dying each year. This figure has greatly reduced from approximately 5 million diarrheal deaths annually 20 years ago, a phenomenon often attributed to the utilization of oral rehydration solution (ORS).
- Knowledge Gap: ORS is very effective in correcting dehydration and reducing mortality, but is not adequately used in many countries, partly due to the fact that it does not reduce diarrhea. The physiological basis for ORS is that glucose-stimulated sodium and fluid absorption is not inhibited by cyclic 3',5'-adenosine monophosphate (cAMP) and other diarrhea mediators which inhibit sodium chloride absorption. The conventional glucose-based ORS does not reduce duration or severity of diarrhea and may in fact paradoxically increase fecal fluid losses. Advances in ORS composition have included the universal adoption of hypo-osmolar ORS (HO-ORS) in 2003. Recent technological innovations have led to the use of amylase-resistant starches and their modifications in the treatment of diarrhea. Short chain fatty acids (SCFA), which are produced in colon from these non-absorbed carbohydrates, enhance sodium absorption. An orally administered, non-absorbed starch (i.e., one resistant to digestion by amylase) significantly reduced fecal fluid loss and the duration of diarrhea in patients with cholera.
- Relevance: Efforts are continuing to improve the efficacy of oral rehydration solution. As glucose stimulates sodium and water absorption in small intestine, short chain fatty acids (SCFAs) stimulate sodium and water absorption in the colon. In cholera, colonic function is also impaired due to the lack of SCFAs. The main source of SCFAs is the unabsorbed carbohydrates that are fermented in the colon by the colonic bacteria. The maize starch contains substantial amount of amylase resistant starch that escapes digestion and absorption in the small intestine and is fermented in the colon, liberating SCFAs. We expect that our experimental ORS containing maize starch will reduce the severity (stool volume) and enhance recovery (reduce duration) of diarrhoea.
তারিখ
| সর্বশেষ যাচাই করা হয়েছে: | 01/31/2014 |
| প্রথম জমা দেওয়া: | 03/26/2013 |
| আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 04/01/2013 |
| প্রথম পোস্ট: | 04/03/2013 |
| সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 04/01/2014 |
| সর্বশেষ আপডেট পোস্ট: | 04/03/2014 |
| আসল অধ্যয়ন শুরুর তারিখ: | 03/31/2013 |
| আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 01/31/2014 |
| আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 01/31/2014 |
অবস্থা বা রোগ
পর্যায়
বাহু গ্রুপ
| বাহু | হস্তক্ষেপ / চিকিত্সা |
|---|---|
| Males Adult 18-65 |
যোগ্যতার মানদণ্ড
| বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
| লিঙ্গ অধ্যয়নের জন্য যোগ্য | Male |
| নমুনা পদ্ধতি | Probability Sample |
| স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
| নির্ণায়ক | INCLUSION CRITERIA: A participant is considered eligible for participation in the trial if the following inclusion criteria are satisfied on admission (Day 1, before randomization) to the hospital: 1. Participant is a male between 18 and 65 years of age inclusive 2. Severe watery diarrhea without fecal blood of less than 48 hours (with passage of 3 or more watery stools in the 24 hours before admission) 3. Signs of severe dehydration as per ICDDR,B guidelines (modified WHO guideline) 4. Dipstick test/Dark-field examination positive for Vibrio cholera 5. Written informed consent is provided 6. Participant is willing and able to comply with all trial requirements EXCLUSION CRITERIA: A participant who meets any of the following criteria on admission (before randomization) to the hospital will not qualify for the study 1. Evidence or history of any clinically significant illness as per the Investigator's discretion. 2. Known case of HIV or Hepatitis B 3. History of cancer 4. Known renal disease 5. Frequent excessive alcohol use, binge drinking (e.g. men consume 5 or more drinks in about 2 hours) or use of illicit drugs within the past two years 6. History of receiving antimicrobial or anti-diarrheal medication (loperamide, diphenoxylate, etc.) within seven days of admission 7. Concomitant infection requiring antimicrobial therapy 8. Donated blood or plasma or experienced clinically significant loss of blood within eight weeks prior to admission or who plan to donate blood within 1 month after study participation 9. Clinically significant abnormal laboratory test results as determined by the investigator 10. Treatment within 30 days prior to admission (or five half-lives of the compound, if longer) with any investigational agent or device 11. History of seizure (including febrile seizure) or loss of consciousness; 12. History of any GI Surgery related to Bowel resections and gastric anastomoses in past except Appendicitis 13. For any reason, deemed by the investigator to be inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator or designee 14. Prior enrolment in this trial |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Duration of Diarrhea [12 hrs w/o diarrhoea, up to max of 96 hrs]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. Stool output and fluid intake rate [0 to 96 hrs]
অন্যান্য ফলাফলের ব্যবস্থা
1. Safety & Tolerability as measured by adverse events, vital signs and lab parameters [Approximately 24 hours after randomization]
