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CTRI Number  CTRI/2024/09/073649 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 18/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   To Evaluate the Impact of Addition of Synbiotic Combination to Lactulose in management of Constipation 
Scientific Title of Study   A Randomized, Multicenter, Open Label, Two Arm, Prospective, Parallel Study to Evaluate the Impact of Addition of Synbiotic Combination to Lactulose in Management of Functional Constipation. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sagar Katare 
Designation  Head - Ideation and Clinical Research - MA 
Affiliation  Dr. Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad Hyderabad TELANGANA 500016 India

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048400  
Email  sagarkatare@drreddys.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachana M Bhoite 
Designation  Head - Nutrition Science & Clinical Nutrition - Nutraceuticals 
Affiliation  Dr. Reddys Laboratories 
Address  Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad Hyderabad TELANGANA 500016 India

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048400  
Email  rachanamb@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Rachana M Bhoite 
Designation  Head - Nutrition Science & Clinical Nutrition - Nutraceuticals 
Affiliation  Dr. Reddys Laboratories 
Address  Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad Hyderabad TELANGANA 500016 India

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048400  
Email  rachanamb@drreddys.com  
 
Source of Monetary or Material Support  
Dr Reddys Laboratories Medical Affairs Department, Dr Reddy Laboratories Ltd, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad Hyderabad TELANGANA 500016 India 
 
Primary Sponsor  
Name  Dr Reddys Laboratories  
Address  7-1-27, Ameerpet Road, Leelanagar, Hyderabad, Telangana 500016 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhileswar Yandamuri  Aditya Multispecialty Hospitals  3rd Line, Gunturvari Thota, Opp.Road RTC Bus Stand, Kamaraju, Scan Centre Road, Guntur, A.P, 522001-India.
Guntur
ANDHRA PRADESH 		 08632220395

nikhileswar.yandamuri@gmail.com 
Dr Rupa Banerjee  AIG Hospitals (A unit of Asian Institute of Gastroenterology Pvt Ltd)  Survey No 136, 4/5, Plot No 2/3, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA 		 9849287530
9849287530
rupabanerjee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee, Asian Institute of Gastroenterology  Approved 
Institutional Ethics Commitee, Aditya Multispecialty Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lactogred-Lactulose & Synbiotic – 25ml  Subjects will be instructed to consume orally approximately 25 mL of test product, daily at night for 28 days 
Comparator Agent  Lactulose - 15ml  Subjects will be instructed to consume orally approximately 15 mL of lactulose solution, daily at night for 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Male or female subjects with age of 18-65 years (both years inclusive).
2)Subject diagnosed with functional constipation/chronic constipation as per Rome IV criteria is two or more of the following: a) Straining during more than ¼ (25%) of defecations b) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations c) Sensation of incomplete evacuation more than ¼ (25%) of defecations d) Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations e) Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) f) Fewer than three SBM per week g) Loose stools are rarely present without the use of laxatives. h) Insufficient criteria for irritable bowel syndrome
3)Subject must be willing and able to administer the study medication as directed, comply with study instructions and commit to all subsequent visits for the duration of the study.
4) Subject who agrees to refrain from making any new, major life-style changes that may have affected constipation symptoms (e.g., starting a new diet, fasting for prolonged duration during study period or changing his or her exercise pattern) from the time of signature of the ICF to the last trial visit.
5) Subject having good general health and free of any disease state or physical condition that might impair evaluation of constipation or which in the Investigators opinion exposes the subject to an unacceptable risk by study participation.
6) Subject and/or LAR willing to give their written informed consent to participate in the study.  
 
ExclusionCriteria 
Details  1.Female subject who is pregnant, lactating or planning to become pregnant during the study.
2.Subject with history of diabetes.
3.Subject with history of hypersensitivity or allergy to active substance and/or any of the study medication ingredients.
4.Subject who have previously undergone any major abdominal surgery.
5.Subject with documented history of slow colonic transit.
6.Subject currently having any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance.
7.Subject having clinical features suggestive of alarming symptoms (e.g., rectal bleeding, weight loss etc.).
8.Subject having family history of peptic ulcer, colorectal cancer or IBD, Abnormal laboratory data or thyroid function.
9.Subject who has used any fiber supplement/laxative/probiotic in the 2 weeks prior to screening or currently using any formulation/ over the counter drugs/ Ayurvedic medicine or following crash diets- intermittent fasting or ketogenic diets.
10.Subject with a structural abnormality of the gastrointestinal (GI) tract or a disease or history of a condition that could affect GI motility.
11.Subject who previously had a fecal impaction that required hospitalization or emergency room treatment, or had a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction (unless successful treatment had been documented by a normal balloon expulsion test).
12.Subject with an acute or chronic condition that, in the investigator’s opinion, would limit the subject’s ability to participate or complete in this study.
13.Subject who has an unstable medical or psychological condition(s) evident prior during screening or that could, in the Investigator’s opinion, be exacerbated during the course of the study.
14.Subject with a recent history (during the 12 months before the Randomization Visit) of drug or alcohol abuse.
15.Subject who has used an Investigational drug in any form or participated in any clinical trial within 30 days prior to first administration of the study medication.
16.Subject who is institutionalized.
17.Subject who lives in the same household as currently enrolled subject.
18.Subject with presence of any other medical condition or abnormal conditions that might adversely impact the safety of the study subjects or confound the study results.
19.For Microbiome cohort - exclude subjects on antibiotics within the last 4 weeks, on probiotics/prebiotics/high fibre supplements for 4-6 weeks 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Treatment success (defined as 3 or more spontaneous stools per week)
2. Change from baseline in weekly frequency of Spontaneous Bowel Movement (SBM)  		 1. Number of stools at baseline (Day 01), Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)].
2. Change from baseline (Day 01) to Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)] 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of subject with complete spontaneous bowel movement (CSBM)
2. Proportion of subject with an SBM within 24 hours after the first dose of study drug.
3. Median time to first CSBM.
4. Change from baseline in stool consistency using Bristol Stool Form Scale (BSFS).
5. Change from Baseline in Weekly Degree of Straining of SBMs
6. Change from Baseline in Weekly Abdominal Bloating Score
7. Change from Baseline in Weekly Abdominal Discomfort Score
8. Difficulty in degree of defecation-sensation of incomplete evacuation
9. Proportion of subject with decrease of at least 30 percentage in Abdominal Pain (AP) scale from baseline.
10. Quality of Life – Modified Patient Assessment of Constipation Quality of Life PAC QOL
11. 3-day Dietary recall by Dietician
12. Food Frequency Questionnaire (FFQ) - Probiotic Foods
13. Gut Microbiota Assessment  		 Change from baseline (Day 01) to Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
This is a randomized, multicenter, open label, two arms, prospective, parallel study to evaluate the impact of addition of synbiotic combination to lactulose in management of functional constipation.
A total of 80 subjects (40 subjects in each group) will be enrolled in this study to get 60 completed subjects (30 subjects in each group) for evaluation at the end of the study.
Note: 40 subjects will be enrolled in the test group and 40 subjects will be enrolled in the reference group.
For Microbiome Cohort – Sample of 24 subjects (12 subjects in each arm) will be analyzed to get data of 20 subjects (10 subjects in each arm) at the end of the study.
Note: Test Group – Sample of 12 subjects. Reference Group – Sample of 12 subjects
The study duration will be of approximately 29 days (4 weeks) which includes screening and treatment period.
Clinical evaluation will be done at following visits:
Visit 1- Day 1: Screening Visit/Randomization Visit/ Baseline Visit (Physical visit)
Visit 2 - Day 8 (± 2 days): Interim visit (Virtual / Telephonic Visit)
Visit 3 - Day 15 (± 2 days): Interim visit (Virtual / Telephonic Visit)
Visit 4 – Day 22 (± 2 days): Interim visit (Virtual / Telephonic Visit)
Visit 5- Day 29 (± 4 days): End of treatment/End of Study/ Early Termination Visit. Visit 5 will be physical for microbiome cohort and can be physical/virtual/telephonic for the rest.
 
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