Comparing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation

NCT06580366 | Not Yet Recruiting Phase 4

• 1 other identifier: HititUniversity-2024-43
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation

Keywords

Bowel preparation; Colonoscopy; sennosid A+B; Sodium Picosulfate

Outcome Measures

Primary Outcomes (1)

• Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study

  Effectiveness of bowel preparation using the Boston Bowel Preparation Scale (BBPS). The BBPS is a standardized 9-point assessment scale for the colon. The structure of the colon is divided into its three segments: right colon, transverse colon, and left colon. Each segment is classified from 0 to 3 depending on the degree of soiling. The sum total of the three segments represents the degree of soiling, so that a total ≤ 5 points shows poor bowel preparation, while 6-7 shows good bowel preparation, and ≥ 8 very good bowel preparation. The investigators will consider patients with a score of 6 or higher as successful.

  4 months

Study Arms (2)

"Sennoside A+B Group" for bowel preparation.

ACTIVE COMPARATOR

This study will compare two bowel preparation methods in patients undergoing colonoscopy: Sennoside A+B Group Intervention: Patients will take Sennoside A+B, a stimulant laxative derived from the senna plant. Purpose: To cleanse the colon by increasing bowel movements and reducing water absorption.

Drug: Sennosid A+B

"PM/Ca Group" for bowel preparation.

ACTIVE COMPARATOR

PM/Ca Group (Sodium Picosulfate/Magnesium Oxide/Citric Acid) Intervention: Patients will take a combination of sodium picosulfate (a stimulant laxative) and magnesium oxide/citric acid (osmotic agents). Purpose: To promote bowel movements by stimulating the bowel and drawing water into the colon.

Drug: Sodium Picosulfate/Magnesium Oxide/Citric Acid

Interventions

Sennosid A+B DRUG

Bowel Preparation

"Sennoside A+B Group" for bowel preparation.

Sodium Picosulfate/Magnesium Oxide/Citric Acid DRUG

Bowel Preparation

"PM/Ca Group" for bowel preparation.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80 years scheduled for elective outpatient colonoscopy.
• Ability to provide informed consent.

You may not qualify if:

• History of intra-abdominal surgery.
• Chronic kidney failure.
• Congestive heart failure.
• Chronic liver failure.
• Inflammatory bowel disease.
• Electrolyte imbalance.
• Hospitalized patients.
• Patients unable to use the bowel preparation treatment
• Known allergy or hypersensitivity to Sennoside A+B or PM/Ca components
• Known gastrointestinal motility disorders.

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University Erol Olcok Training and Research Hospital

Çorum, 19030, Turkey (Türkiye)

Location

Related Publications (5)

• Park S, Lim YJ. Adjuncts to colonic cleansing before colonoscopy. World J Gastroenterol. 2014 Mar 21;20(11):2735-40. doi: 10.3748/wjg.v20.i11.2735.

  PMID: 24659864 BACKGROUND

• Coskun Y, Yuksel I. Polyethylene glycol versus split high-dose senna for bowel preparation: A comparative prospective randomized study. J Gastroenterol Hepatol. 2020 Nov;35(11):1923-1929. doi: 10.1111/jgh.15101. Epub 2020 Jun 8.

  PMID: 32424868 BACKGROUND

• Shavakhi A, Kianinia M, Torabi G, Nemati A, Saeidian B, Hoseinzadeh M, Madjlesi F, Navaei P, Rashidinejad F, Minakari M. High dose Senna or Poly Ethylene Glycol (PEG) for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial. J Res Med Sci. 2011 Feb;16(2):149-55.

  PMID: 22091224 BACKGROUND

• Katz PO, Rex DK, Epstein M, Grandhi NK, Vanner S, Hookey LC, Alderfer V, Joseph RE. A dual-action, low-volume bowel cleanser administered the day before colonoscopy: results from the SEE CLEAR II study. Am J Gastroenterol. 2013 Mar;108(3):401-9. doi: 10.1038/ajg.2012.441. Epub 2013 Jan 15.

  PMID: 23318484 BACKGROUND

• Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11.

  PMID: 31295746 BACKGROUND

MeSH Terms

Interventions

picosulfate sodium

Study Officials

• İbrahim Durak

  Hitit University

  STUDY CHAIR

Central Study Contacts

İbrahim Durak

CONTACT

+903642193000; durak.ibrahim@gmail.com

İbrahim Durak

CONTACT

+903642193000

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 30, 2024
• Study Start: August 22, 2024
• Primary Completion: December 22, 2024
• Study Completion: March 22, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

TU (1)