Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
Study NCT ID:
NCT06580366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-30
First Post:
2024-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation
Sponsor:
Hitit University
Organization:
Study Overview
Official Title:
Sennosid A+B Versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation; A Prospective Randomized Observer-Blinded Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colonoscopy Preparation: Comparing Sennoside A+B and PM/Ca
Colonoscopy is a test used to examine the inside of the bowel. Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure.
What is Sennoside A+B? Sennoside A+B is a type of laxative made from the senna plant. It works by stimulating the bowel to move and reducing the absorption of water, making it easier to pass stools. Research has shown that high doses of sennoside A+B can be effective for bowel preparation.
Sennoside A+B vs. PEG:
Some studies have found that sennoside A+B is more effective than PEG, another laxative, but can cause more abdominal pain. Other studies have found no significant difference in effectiveness between the two.
What is Picosulfate/Magnesium Oxide/Citric Acid (PM/Ca)? PM/Ca is a combination of sodium picosulfate, magnesium oxide, and citric acid. Sodium picosulfate stimulates bowel movements, while magnesium oxide and citric acid help increase water in the bowel, making it easier to pass stools.
PM/Ca vs. PEG:
Research has shown that PM/Ca is as effective as PEG for bowel preparation. Patients using PM/Ca generally tolerate the preparation process better than those using PEG.
Conclusion:
While PEG is the preferred option according to guidelines, its high cost can make it less accessible in some places. In this study, we aim to compare the effectiveness and patient tolerance of Sennoside A+B and PM/Ca since no direct comparison between these two preparations has been made before.
Colonoscopy is a test used to examine the inside of the bowel. Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure.
What is Sennoside A+B? Sennoside A+B is a type of laxative made from the senna plant. It works by stimulating the bowel to move and reducing the absorption of water, making it easier to pass stools. Research has shown that high doses of sennoside A+B can be effective for bowel preparation.
Sennoside A+B vs. PEG:
Some studies have found that sennoside A+B is more effective than PEG, another laxative, but can cause more abdominal pain. Other studies have found no significant difference in effectiveness between the two.
What is Picosulfate/Magnesium Oxide/Citric Acid (PM/Ca)? PM/Ca is a combination of sodium picosulfate, magnesium oxide, and citric acid. Sodium picosulfate stimulates bowel movements, while magnesium oxide and citric acid help increase water in the bowel, making it easier to pass stools.
PM/Ca vs. PEG:
Research has shown that PM/Ca is as effective as PEG for bowel preparation. Patients using PM/Ca generally tolerate the preparation process better than those using PEG.
Conclusion:
While PEG is the preferred option according to guidelines, its high cost can make it less accessible in some places. In this study, we aim to compare the effectiveness and patient tolerance of Sennoside A+B and PM/Ca since no direct comparison between these two preparations has been made before.
Detailed Description:
Colonoscopy is an endoscopic imaging method used to examine the lumen and mucosa of the bowel. It is the gold standard method used for colorectal cancer screening and the detection of most colorectal pathologies. Successful bowel preparation is one of the key factors for a successful colonoscopic examination.
Sennoside A+B is a stimulant laxative derived from the senna plant (Cassia senna). Studies have shown that after senna is ingested, it is activated by the gut flora, directly interacts with the intestinal mucosa, stimulates bowel movements, and inhibits the absorption of electrolytes and water. High doses of senna have been shown to be beneficial as a bowel preparation agent.
There are many studies in the literature comparing senna compounds with polyethylene glycol (PEG) solutions. In a randomized controlled study conducted by Coskun et al. on 474 patients, it was found that bowel cleansing was better with sennoside A+B compared to PEG, but abdominal pain was more common in the senna group. Another randomized controlled study conducted by Shavakhi et al. on 322 patients found no difference in effectiveness between the two agents.
Drugs containing sodium picosulfate-magnesium oxide-citric acid (PM/Ca) are laxative agents recommended for colonoscopy preparation in ESGE and ASGE guidelines. While sodium picosulfate acts as a stimulant laxative, magnesium oxide and citric acid act as osmotic laxatives.
In the SEE CLEAR II randomized controlled trial comparing PM/Ca with PEG, PM/Ca was found to be as effective as PEG. No significant difference was found between the two groups in terms of side effects, but participants using PM/Ca tolerated the bowel preparation procedure much better.
The ASGE and ESGE guidelines primarily recommend PEG solutions for colon preparation. However, due to the lack of reimbursement by the Social Security Institution (SGK) in our country and the resulting cost, access to PEG treatment is difficult for patients. For these reasons, other treatments recommended in the available guidelines are used more frequently in our country.
Although there are many studies in the literature comparing PM/Ca and sennoside A+B preparations with PEG and other preparations in terms of efficacy for bowel preparation, no study has directly compared PM/Ca with sennoside A+B to date. We aimed to compare the efficacy and patient tolerance of these two commonly used preparations in our country.
Sennoside A+B is a stimulant laxative derived from the senna plant (Cassia senna). Studies have shown that after senna is ingested, it is activated by the gut flora, directly interacts with the intestinal mucosa, stimulates bowel movements, and inhibits the absorption of electrolytes and water. High doses of senna have been shown to be beneficial as a bowel preparation agent.
There are many studies in the literature comparing senna compounds with polyethylene glycol (PEG) solutions. In a randomized controlled study conducted by Coskun et al. on 474 patients, it was found that bowel cleansing was better with sennoside A+B compared to PEG, but abdominal pain was more common in the senna group. Another randomized controlled study conducted by Shavakhi et al. on 322 patients found no difference in effectiveness between the two agents.
Drugs containing sodium picosulfate-magnesium oxide-citric acid (PM/Ca) are laxative agents recommended for colonoscopy preparation in ESGE and ASGE guidelines. While sodium picosulfate acts as a stimulant laxative, magnesium oxide and citric acid act as osmotic laxatives.
In the SEE CLEAR II randomized controlled trial comparing PM/Ca with PEG, PM/Ca was found to be as effective as PEG. No significant difference was found between the two groups in terms of side effects, but participants using PM/Ca tolerated the bowel preparation procedure much better.
The ASGE and ESGE guidelines primarily recommend PEG solutions for colon preparation. However, due to the lack of reimbursement by the Social Security Institution (SGK) in our country and the resulting cost, access to PEG treatment is difficult for patients. For these reasons, other treatments recommended in the available guidelines are used more frequently in our country.
Although there are many studies in the literature comparing PM/Ca and sennoside A+B preparations with PEG and other preparations in terms of efficacy for bowel preparation, no study has directly compared PM/Ca with sennoside A+B to date. We aimed to compare the efficacy and patient tolerance of these two commonly used preparations in our country.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: