[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cic":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100626155","phase-4-efficacy-and-safety-of-linaclotide-in-chronic-constipation-100626155",false,"NCT07431957","\"Efficacy and Safety of Linaclotide in Chronic Constipation\"","\"Efficacy and Safety of Linaclotide in Chronic Constipation : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study\"","LIN-CC-BD","Inclusion Criteria:\n\n* Adult patients (18-70 years)\n* patients diagnosed with CIC or IBS-C based on Rome IV criteria\n* No abnormal finding on colonoscopy conducted within past 1 year\n* Patients who can read and are willing to complete daily bowel diary and follow study procedures\n\nExclusion Criteria:\n\n* Clinical features suggestive of organic disease ( Anaemia, unexplained weight loss, per rectal bleeding, family history of malignancy)\n* Secondary constipation due to structural, metabolic, or neurological causes (IBD, Colorectal cancer, hypothyroidism, hypercalcemia, DM, Parkinson's disease)\n* History of or new onset intestinal obstruction\n* Prior history of stomach, small intestine and colorectal surgery ( except appendectomy or hemorroidectomy)\n* 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)\n* Use of medication affecting bowel motility ( Lubiprostone, Elobixibat, PEG or prosecretory agents) within 2 week before enrollment\n* Serious cardiovascular, respiratory, renal, GI, hepatic, hematological, neurological or psychiatric illness\n* Pregnancy or lactation","ALL","18 Years","70 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","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?\"\n\nStudy procedure:\n\nFrom 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.",[28,29,30,31,32],"Chronic Idiopathic Constipation","Irritable Bowel Syndrome (IBS-C)","Chronic Constipation","CIC","Constipation Predominant Irritable Bowel Syndrome",[34,31,35,36,37,38,39,15,40,29],"CC","IBS-C","Chronic Constipation (CC)","Chronic Idiopathic Constipation (CIC)","Constipation predominant Irritable Bowel Syndrome (IBS-C)","Linaclotide","Linaclotide RCT","NOT_YET_RECRUITING","2026-02-21",{"date":44,"type":45},"2026-02-25","ACTUAL",{"date":47,"type":22},"2026-02-20",{"date":49,"type":22},"2027-01-31",{"name":51,"class":52},"Md Mehedi Shahriar","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":248,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":5},"100151071","online-study-of-people-who-have-genetic-changes-and-features-of-autism-simons-searchlight-100151071","NCT01238250","Online Study of People Who Have Genetic Changes and Features of Autism: Simons Searchlight","Inclusion Criteria:\n\n* Subjects of any age with a genetic condition on our eligible list along with their biological family members. Current list can be found at: https:\u002F\u002Fwww.simonssearchlight.org\u002Fresearch\u002Fwhat-we-study\u002F\n* Must be fluent in English or a supported language. Current supported languages are Spanish, French, and Dutch, with more to come.\n* Able to register and participate through our online platform, which can be accessed through any device able to connect to the internet.\n* Able and willing to provide consent.\n\nExclusion Criteria:\n\n-Some genetic changes that we study have regions or variants that are not eligible for our research. This is determined during our laboratory review that is completed by trained and certified genetic counselors. These specific ineligible regions or variants can change frequently.",{"count":61,"type":22},100000,"OBSERVATIONAL","Simons Searchlight is an observational, online, international research program for families with rare genetic variants that cause neurodevelopmental disorders and may be associated with autism. Simons Searchlight collects medical, behavioral, learning, and developmental information from people who have these rare genetic changes. The goal of this study is to improve the clinical care and treatment for these people. Simons Searchlight partners with families to collect data and distribute it to qualified researchers.",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,31,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247],"16P11.2 Deletion Syndrome","16p11.2 Duplications","1Q21.1 Deletion","1Q21.1 Microduplication Syndrome (Disorder)","ACTL6B","ADNP","AHDC1","ANK2","ANKRD11","ARID1B","ASH1L","BCL11A","CHAMP1","CHD2","CHD8","CSNK2A1","CTBP1","CTNNB1 Gene Mutation","CUL3","DDX3X","DNMT3A","DSCAM","DYRK1A","FOXP1","GRIN2A","GRIN2B","HIVEP2-Related Intellectual Disability","HNRNPH2","KATNAL2","KDM5B","KDM6B","KMT2C Gene Mutation","KMT2E","KMT5B","MBD5","MED13L","PACS1","PPP2R5D-Related Intellectual Disability","PTCHD1","REST","SCN2A Encephalopathy","SETBP1 Gene Mutation","SETD5","SMARCA4 Gene Mutation","SMARCC2","STXBP1 Encephalopathy With Epilepsy","SYNGAP1-Related Intellectual Disability","TBR1","ARHGEF9","HNRNPU","PPP3CA","PPP2R1A","SLC6A1","2p16.3 Deletions","5q35 Deletions","5q35 Duplications","7q11.23 Duplications","15Q13.3 Deletion Syndrome","16p11.2 Triplications","16P12.2 Microdeletion","16P13.11 Microdeletion Syndrome (Disorder)","17Q12 Microdeletion Syndrome (Disorder)","17Q12 Duplication Syndrome","17Q21.31 Deletion Syndrome","17q21.3 Duplications","ACTB","ADSL","AFF2","ALDH5A1","ANK3","ARX","ATRX Gene Mutation","AUTS2 Syndrome","BCKDK","BRSK2","CACNA1C","CAPRIN1","CASK","CASZ1","CHD3","CNOT3","CREBBP Gene Mutation","CSDE1","CTCF","DEAF1","DHCR7","DLG4","EBF3","EHMT1","EP300 Gene Mutation","GIGYF1","GRIN1","GRIN2D","IQSEC2-Related Syndromic Intellectual Disability","IRF2BPL","KANSL1","KCNB1","KDM3B","NEXMIF","KMT2A","MBOAT7","MEIS2","MYT1L","NAA15","NBEA","NCKAP1","NIPBL","NLGN2","NLGN3","NLGN4X","NR4A2","NRXN1","NRXN2","NSD1 Gene Mutation","PHF21A","PHF3","PHIP","POMGNT1","PSMD12","RELN","RERE","RFX3","RIMS1","RORB","SCN1A","SETD2 Gene Mutation","SHANK2","SIN3A","SLC9A6","SON","SOX5","SPAST","SRCAP","TAOK1","TANC2","TCF20","TLK2","TRIO","TRIP12","UPF3B","USP9X","VPS13B","WAC","WDFY3","ZBTB20","ZNF292","ZNF462","2Q37 Deletion Syndrome","9q34 Duplications","15q15 Deletions","15Q24 Deletion","NR3C2","SYNCRIP","2q34 Duplication","2q37.3 Deletion","6q16 Deletion","15q11.2 BP1-BP2 Deletion","16p13.3 Deletion","17Q11.2 Microduplication Syndrome (Disorder)","17p13.3","Xq28 Duplication","CLCN4","CSNK2B","DYNC1H1","EIF3F","GNB1","MED13","MEF2C","RALGAPB","SCN1B","YY1","Xp11.22 Duplication","PACS2","MAOA","MAOB","HNRNPC","HNRNPD","HNRNPK","HNRNPR","HNRNPUL2","5P Deletion Syndrome","TCF7L2 Gene Mutation","HECW2",[249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,70,73,74,270,69,71,271,72,75,76,78,79,272,83,87,88,90,95,97,99,100,104,273,109,274,275,92,276,77,80,81,84,85,86,89,93,94,277,98,278,101,103,279,107,280,281,112,113,114,282,116,117,237,238,239,240,241,242,243,244,245,283,247],"16p11.2","16p11.2 del","16p11.2 deletion","16p11.2 dup","16p11.2 duplication","chromosome 16","chromosome 16p","chromosome 16p11","chromosome 16p11.2","1q21.1","1q21.1 del","1q21.1 deletion","1q21.1 dup","1q21.1 duplication","chromosome 1","chromosome 1q","chromosome 1q21","chromosome 1q21.1","genetic mutation","genetic variant","gene variant","ASXL3","BAF190","CTNNB1","SCN2A","SYNGAP1","HIVEP2","PPP2R5D","KMT2C","SUV420H1","SETBP1","SMARCA4","STXBP1","PPP2B","TCF7L2","RECRUITING","2025-06-03",{"date":287,"type":45},"2025-06-06",{"date":289,"type":4},"2010-10",{"date":291,"type":22},"2050-10",{"name":293,"class":52},"Simons Searchlight"]