Menu
Not yet recruiting NCT06580366

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

Phase IV Interventional Bowel Preparation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sennosid A+B, Sodium Picosulfate/Magnesium Oxide/Citric Acid.
Who it may be relevant to
Registry conditions: Bowel Preparation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Drug Sennosid A+B
    Bowel Preparation
  • Drug Sodium Picosulfate/Magnesium Oxide/Citric Acid
    Bowel Preparation

Primary outcome measures

  • Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study [Time frame: 4 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Screening

Study locations

Turkey (Türkiye) · 1 center
  • Hitit University Erol Olcok Training and Research Hospital — Çorum

Publications

  • 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
  • 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
  • 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
  • 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
  • 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 PMID 31295746
  • Durak I, Ozden M, Duzenli T, Sadecolak M, Kaya M, Koseoglu H. Comparison of sennoside A + B and sodium picosulfate-based regimens for bowel preparation: a prospective randomized trial. Tech Coloproctol. 2026 May 14;30(1):108. doi: 10.1007/s10151-026-03336-2. PMID 42135569

Identifiers

NCT: NCT06580366 · HititUniversity-2024-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗