Chronic Idiopathic ConstipationPhase 4LIN-CC-BDNCT07431957
"Efficacy and Safety of Linaclotide in Chronic Constipation"
A Phase 4 study testing Linaclotide 72 micrograms and Linaclotide 145 micrograms in people with Chronic Idiopathic Constipation and Irritable Bowel Syndrome (IBS-C), run by Md Mehedi Shahriar at 1 site in Bangladesh.
Trial summary
Goal of this study is to evaluate the efficacy and safety of two different doses of Linaclotide in improving bowel function and patient-reported outcomes among Bangladeshi patients with chronic constipation for 8 weeks along with an additional short drug-free follow up period of 2 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C), Chronic Constipation
- What is being tested?
- Linaclotide 72 micrograms and Linaclotide 145 micrograms
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBangladesh
- Study dates
- 20 Feb 2026to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-70 years)
- patients diagnosed with CIC or IBS-C based on Rome IV criteria
- No abnormal finding on colonoscopy conducted within past 1 year
- Patients who can read and are willing to complete daily bowel diary and follow study procedures
Who cannot join
- Clinical features suggestive of organic disease ( Anaemia, unexplained weight loss, per rectal bleeding, family history of malignancy)
- Secondary constipation due to structural, metabolic, or neurological causes (IBD, Colorectal cancer, hypothyroidism, hypercalcemia, DM, Parkinson's disease)
- History of or new onset intestinal obstruction
- Prior history of stomach, small intestine and colorectal surgery ( except appendectomy or hemorroidectomy)
- Patients currently suffering from medication induced costipation ( opioids, anti choline raids, calcium channel blockers, oral iron and calcium supplements, anti-Parkinsonian drug, antipsychotic, anti-emetics or psychostimulant drugs)
- Use of medication affecting bowel motility ( Lubiprostone, Elobixibat, PEG or prosecretory agents) within 2 week before enrollment
- Serious cardiovascular, respiratory, renal, GI, hepatic, hematological, neurological or psychiatric illness
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Dhaka Medical College
Dhaka
Md Mehedi Shahriar, +8801753085062, msreehan85@gmail.com
About this study
Official title: "Efficacy and Safety of Linaclotide in Chronic Constipation : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study"
Goal of this study is to evaluate the efficacy and safety of two different doses of Linaclotide in improving bowel function and patient-reported outcomes among Bangladeshi patients with chronic constipation for 8 weeks along with an additional short drug-free follow up period of 2 weeks. The main question it aims to answer is "Does Linaclotide at doses of 72microgram or 145microgram once daily improve bowel function and patient-reported coutcomes compared with placebo in Bangladeshi patients with chronic constipation over an 8-week treatment period?"
Study procedure:
From outpatient department of Gastroenterology, Dhaka Medical College, a total of 90 adult patients diagnosed with chronic idiopathic constipation (CIC) or constipation predominant irritable bowel syndrome (IBS-C) by ROME-IV criteria will be selected after baseline evaluation including clinical history, physical examination, laboratory tests and colonoscopy. Before enrollment eligible participants will undergo 1-week baseline stool diary which will include baseline data of patient reported severity of abdominal symptoms (bowel movement, stool frequency, bloating, abdominal pain or discomfort and defecatory satisfaction score). Patients reporting more than 3 SBMs during baseline run in period will be excluded from the study. Finally total 90 patients will be enrolled as participants who will be randomly assigned to one of the three groups, Group A (Linaclotide 72mcg once daily), Group B (Linaclotide 145mcg once daily) and Group C (Placebo once daily ). The treatment period will start from randomization visit (day 0) and will be continued for 8 weeks. All participants will receive identical looking drugs (72mcg or 145mcg or placebo) 30 minutes before breakfast and they will be requested to maintain standard dietary and lifestyle advices including increased intake of high fiber diet and fluid throughout the study. Patients will record spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM), stool consistency using Bristol Stool Form Scale (BSFS), severity of abdominal symptoms by 5-point Likert scale, use of rescue medication after 3 days of absolute constipation and adverse events such as diarrhea in their daily stool diary. They will be followed up at week-4, week-8 and after 2-week drug free withdrawal period at week-10 with review of stool diary and safety assessments. Entire study will be monitored by Data Safety Monitoring Board (DSMB) of Dhaka Medical College.
- Conditions
- Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C), Chronic Constipation, CIC, Constipation Predominant Irritable Bowel Syndrome
- Being tested
- Linaclotide 72 micrograms, Linaclotide 145 micrograms, Placebo
- Keywords
- CC, CIC, IBS-C, Chronic Constipation (CC), Chronic Idiopathic Constipation (CIC), Constipation predominant Irritable Bowel Syndrome (IBS-C), Linaclotide, LIN-CC-BD, Linaclotide RCT, Irritable Bowel Syndrome (IBS-C)
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linaclotide 72 microgramsDrug
Linaclotide 72 micrograms will be given in Group A
Linaclotide 145 microgramsDrug
Linaclotide 145 micrograms will be given in Group B
PlaceboOther
Placebo will be given in Group C
| Study group | Role | What they receive |
|---|---|---|
| Linaclotide 72 | Experimental | Group A - Linaclotide 72 mcg Receives: Drug: Linaclotide 72 micrograms |
| Linaclotide 145 | Experimental | Group B - Linaclotide 145 mcg Receives: Drug: Linaclotide 145 micrograms |
| Placebo | Placebo comparator | Group C - Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Spontaneous Bowel Movement (CSBM) responder rate
Complete Spontaneous Bowel Movement (CSBM) responder rate is defined as the proportion of patients achieving 3 or more complete spontaneous bowel movements (CSBM) per week with an increase of 1 or more CSBM per week from baseline for at least 6 of the treatment weeks. Patient will be maintaining a daily stool diary from which data will be obtained and CSBM responder rate will be assessed.
Measured: 8 weeks
Secondary outcomes (10)
Mean change in weekly SBM frequency
Mean change in weekly Spontaneous Bowel Movement (SBM) after 8 weeks from baseline.
Measured: 8 weeks
Mean change in CSBM frequency
Mean change in weekly Complete Spontaneous Bowel Movement (CSBM) after 8 weeks from baseline
Measured: 8 weeks
Changes in weekly stool consistency measured by Bristol Stool Form Scale (BSFS)
Change in weekly stool consistency from baseline using Bristol Stool Form Scale (BSFS). The scale consists of various stool forms from type 1 to type 7. (Type 1- separate hard lumps, like nuts and hard to pass, Type 2-sausage shaped but lumpy, Type 3- Like a sausage but with cracks on the surface, Type 4- Like a sausage or snake, smooth and soft, Type 5- soft blobs with clear cut edges, Type 6- fluffy pieces ragged edges, a mushy stool, Type 7- watery, no solid pieces, entirely liquid).
Measured: 8 weeks
Change in average weekly bloating score
Change in average weekly bloating score from baseline to week-8 using a 5-point Likert scale .
Bloating means subjective abdominal fullness or distension reported by the patient.
Bloating score is evaluated on a 5-point Likert scale (From 1 to 5, higher score means worse outcome)
Measured: 8 weeks
Change in weekly straining score
Change in weekly straining score from baseline to week-8 will be measured using 5-point Likert scale (from 1 to 5, higher score means worse outcome)
Measured: 8 weeks
Change in weekly abdominal pain or discomfort score
Change in weekly abdominal pain or discomfort score from baseline to week-8 will be measured using 5-point Likert scale (from 1 to 5, higher score means worse outcome)
Measured: 8 weeks
Change in satisfaction score related to defecation
Satisfaction score related to defecation will be measured using 5-point defecatory satisfaction score (Likert scale, from 1 to 5, lower score means worse outcome) and change will be compared between baseline value and week-8 value.
Measured: 8 weeks
Patient reported adverse events
Patient-reported adverse events associated with Linaclotide treatment will be documented according to common terminology criteria for adverse events (CTCAE grading).
Measured: Through study completion, an average of 10 weeks
Sustainability of treatment effects
Sustainability of treatment effects:
Sustainability will be defined as maintenance of improved symptom scores during the 2 week drug free follow up period after week-8 at levels that are not statistically significantly worse than end of treatment values and remain no worse than baseline.
These symptom scores includes weekly spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) frequency, stool consistency measured by Bristol Stool Form scale (BSFS, from type 1 to 7), abdominal symptom scores including bloating score, straining score, abdominal pain or discomfort scores using 5-point Likert scale (1 to 5, higher score means worse outcome), satisfaction score related to defecation using 5-point Likert scale (1 to 5, Lower score means worse outcome) etc.
Measured: 2 week of drug free follow up period (from week-9 to week-10)
Potentially rebound of symptoms
Rebound of symptoms:
Rebound will be defined as worsening of symptom measures beyond baseline levels during the drug free follow up period.
These symptom scores includes weekly spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) frequency, stool consistency measured by Bristol Stool Form scale (BSFS, from type 1 to 7), abdominal symptom scores including bloating score, straining score, abdominal pain or discomfort scores using 5-point Likert scale (1 to 5, higher score means worse outcome), satisfaction score related to defecation using 5-point Likert scale (1 to 5, Lower score means worse outcome) etc.
Measured: 2 week of drug free follow up period (from week-9 to week-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic ConstipationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV investigator initiated trial with off-label dose evaluation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Md Mehedi Shahriar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Md Mehedi Shahriar, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431957
- Sponsor's protocol ID
- IRB-DMC/2025/261
- Acronym
- LIN-CC-BD
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy and Safety of Linaclotide in Chronic Constipation : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study"
- ClinicalTrials.gov ID
- NCT07431957
- Acronym / sponsor ID
- LIN-CC-BD / IRB-DMC/2025/261
- Conditions
- Chronic Idiopathic Constipation, Irritable Bowel Syndrome (IBS-C), Chronic Constipation, CIC, Constipation Predominant Irritable Bowel Syndrome
- Keywords
- CC, CIC, IBS-C, Chronic Constipation (CC), Chronic Idiopathic Constipation (CIC), Constipation predominant Irritable Bowel Syndrome (IBS-C), Linaclotide, LIN-CC-BD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Md Mehedi ShahriarUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 25 Feb 2026 (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.
Goal of this study is to evaluate the efficacy and safety of two different doses of Linaclotide in improving bowel function and patient-reported outcomes among Bangladeshi patients with chronic constipation for 8 weeks along with an additional short drug-free follow up period of 2 weeks. The main question it aims to answer is "Does Linaclotide at doses of 72microgram or 145microgram once daily improve bowel function and patient-reported coutcomes compared with placebo in Bangladeshi patients with chronic constipation over an 8-week treatment period?"
Study procedure:
From outpatient department of Gastroenterology, Dhaka Medical College, a total of 90 adult patients diagnosed with chronic idiopathic constipation (CIC) or constipation predominant irritable bowel syndrome (IBS-C) by ROME-IV criteria will be selected after baseline evaluation including clinical history, physical examination, laboratory tests and colonoscopy. Before enrollment eligible participants will undergo 1-week baseline stool diary which will include baseline data of patient reported severity of abdominal symptoms (bowel movement, stool frequency, bloating, abdominal pain or discomfort and defecatory satisfaction score). Patients reporting more than 3 SBMs during baseline run in period will be excluded from the study. Finally total 90 patients will be enrolled as participants who will be randomly assigned to one of the three groups, Group A (Linaclotide 72mcg once daily), Group B (Linaclotide 145mcg once daily) and Group C (Placebo once daily ). The treatment period will start from randomization visit (day 0) and will be continued for 8 weeks. All participants will receive identical looking drugs (72mcg or 145mcg or placebo) 30 minutes before breakfast and they will be requested to maintain standard dietary and lifestyle advices including increased intake of high fiber diet and fluid throughout the study. Patients will record spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM), stool consistency using Bristol Stool Form Scale (BSFS), severity of abdominal symptoms by 5-point Likert scale, use of rescue medication after 3 days of absolute constipation and adverse events such as diarrhea in their daily stool diary. They will be followed up at week-4, week-8 and after 2-week drug free withdrawal period at week-10 with review of stool diary and safety assessments. Entire study will be monitored by Data Safety Monitoring Board (DSMB) of Dhaka Medical College.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Phase IV investigator initiated trial with off-label dose evaluation
| Arm | Type | Receives |
|---|---|---|
| Linaclotide 72 | Experimental | Drug: Linaclotide 72 microgramsGroup A - Linaclotide 72 mcg |
| Linaclotide 145 | Experimental | Drug: Linaclotide 145 microgramsGroup B - Linaclotide 145 mcg |
| Placebo | Placebo comparator | Other: PlaceboGroup C - Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18-70 years)
- patients diagnosed with CIC or IBS-C based on Rome IV criteria
- No abnormal finding on colonoscopy conducted within past 1 year
- Patients who can read and are willing to complete daily bowel diary and follow study procedures
Key exclusion criteria (8 listed)
- Clinical features suggestive of organic disease ( Anaemia, unexplained weight loss, per rectal bleeding, family history of malignancy)
- Secondary constipation due to structural, metabolic, or neurological causes (IBD, Colorectal cancer, hypothyroidism, hypercalcemia, DM, Parkinson's disease)
- History of or new onset intestinal obstruction
- Prior history of stomach, small intestine and colorectal surgery ( except appendectomy or hemorroidectomy)
- Patients currently suffering from medication induced costipation ( opioids, anti choline raids, calcium channel blockers, oral iron and calcium supplements, anti-Parkinsonian drug, antipsychotic, anti-emetics or psychostimulant drugs)
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 |
|---|---|---|
| Linaclotide 72 microgramsLinaclotide 72 micrograms will be given in Group A | Drug | Linaclotide 72 |
| Linaclotide 145 microgramsLinaclotide 145 micrograms will be given in Group B | Drug | Linaclotide 145 |
| PlaceboPlacebo will be given in Group C | Other | Placebo |
Primary outcome
Complete Spontaneous Bowel Movement (CSBM) responder rate
Time frame: 8 weeks
Complete Spontaneous Bowel Movement (CSBM) responder rate is defined as the proportion of patients achieving 3 or more complete spontaneous bowel movements (CSBM) per week with an increase of 1 or more CSBM per week from baseline for at least 6 of the treatment weeks. Patient will be maintaining a daily stool diary from which data will be obtained and CSBM responder rate will be assessed.
10 secondary outcomes
Mean change in weekly SBM frequency
Time frame: 8 weeks
Mean change in CSBM frequency
Time frame: 8 weeks
Changes in weekly stool consistency measured by Bristol Stool Form Scale (BSFS)
Time frame: 8 weeks
Change in average weekly bloating score
Time frame: 8 weeks
Change in weekly straining score
Time frame: 8 weeks
Change in weekly abdominal pain or discomfort score
Time frame: 8 weeks
Change in satisfaction score related to defecation
Time frame: 8 weeks
Patient reported adverse events
Time frame: Through study completion, an average of 10 weeks
Sustainability of treatment effects
Time frame: 2 week of drug free follow up period (from week-9 to week-10)
Potentially rebound of symptoms
Time frame: 2 week of drug free follow up period (from week-9 to week-10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
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 Linaclotide 72 micrograms and Linaclotide 145 micrograms in people with Chronic Idiopathic Constipation and Irritable Bowel Syndrome (IBS-C), run by Md Mehedi Shahriar at 1 site in Bangladesh.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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 Bangladesh. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Md Mehedi Shahriar, MBBS (+8801753085062, msreehan85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Spontaneous Bowel Movement (CSBM) responder rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.