Bowel PreparationPhase 4NCT06580366
Comparing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation
A Phase 4 study testing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid in people with Bowel Preparation, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Aug 2024to 22 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years scheduled for elective outpatient colonoscopy.
- Ability to provide informed consent.
Who cannot join
- History of intra-abdominal surgery.
- Chronic kidney failure.
- Congestive heart failure.
- Chronic liver failure.
- Inflammatory bowel disease.
- Electrolyte imbalance.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
İbrahim Durak contact
Turkey (Türkiye)1 site
Hitit University Erol Olcok Training and Research Hospital
Çorum, 19030
İbrahim Durak
About this study
Official title: Sennosid A+B Versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation; A Prospective Randomized Observer-Blinded Study
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.
Read more
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.
Read the 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.
- Conditions
- Bowel Preparation
- Being tested
- Sennosid A+B, Sodium Picosulfate/Magnesium Oxide/Citric Acid
- Keywords
- Bowel preparation, Colonoscopy, sennosid A+B, Sodium Picosulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sennosid A+BDrug
Bowel Preparation
Sodium Picosulfate/Magnesium Oxide/Citric AcidDrug
Bowel Preparation
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Drug: Sodium Picosulfate/Magnesium Oxide/Citric Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start22 Aug 2024 (estimated)
- Primary completion22 Dec 2024 (estimated)
- Study completion22 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Durak, Hitit University
- Investigators
- İbrahim Durak, Study chair, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580366
- Sponsor's protocol ID
- HititUniversity-2024-43
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24659864Coskun 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.
PubMed 32424868Shavakhi 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.
PubMed 22091224Katz 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.
PubMed 23318484Hassan 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.
PubMed 31295746Durak 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.
PubMed 42135569
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sennosid A+B Versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation; A Prospective Randomized Observer-Blinded Study
- ClinicalTrials.gov ID
- NCT06580366
- Acronym / sponsor ID
- HititUniversity-2024-43
- Conditions
- Bowel Preparation
- Keywords
- Bowel preparation, Colonoscopy, sennosid A+B, Sodium Picosulfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 22 Aug 2024 (estimated)
- Primary completion
- 22 Dec 2024 (estimated)
- Study completion
- 22 Mar 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Sennoside A+B Group" for bowel preparation. | Active comparator | Drug: Sennosid A+BThis 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. |
| "PM/Ca Group" for bowel preparation. | Active comparator | Drug: Sodium Picosulfate/Magnesium Oxide/Citric AcidPM/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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-80 years scheduled for elective outpatient colonoscopy.
- Ability to provide informed consent.
Key exclusion criteria (10 listed)
- History of intra-abdominal surgery.
- Chronic kidney failure.
- Congestive heart failure.
- Chronic liver failure.
- Inflammatory bowel disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sennosid A+BBowel Preparation | Drug | "Sennoside A+B Group" for bowel preparation. |
| Sodium Picosulfate/Magnesium Oxide/Citric AcidBowel Preparation | Drug | "PM/Ca Group" for bowel preparation. |
Primary outcome
Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study
Time frame: 4 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 24659864Park 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.
- Background: PubMed 32424868Coskun 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.
- Background: PubMed 22091224Shavakhi 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.
- Background: PubMed 23318484Katz 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.
- Background: PubMed 31295746Hassan 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.
- Derived from this study: PubMed 42135569Durak 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İbrahim Durak contact
İbrahim Durak study chair
Hitit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid in people with Bowel Preparation, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İbrahim Durak (+903642193000, durak.ibrahim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580366, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.