Ignite Creation Date:
2024-05-06 @ 12:37 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01618617
Status:
UNKNOWN
Last Update Posted:
2012-11-30
First Post:
2012-06-11
Brief Title:
Multistrain Probiotic for Functional Constipation
Sponsor:
Renew Life Formulas Inc
Organization:
Renew Life Formulas Inc
Study Overview
Official Title:
Dose-response Effectiveness of 6-week Multistrain Probiotic Supplementation on Whole Gut Transit Time Quality of Life and Gastrointestinal Symptoms in Adults With Functional Constipation
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects will be screened and will enter a placebo-only 2-week run-in period during which constipation symptoms will be evaluated and any disallowed products eg probiotics must be discontinued Following successful completion of the run-in period subjects will be randomized to probiotic high or low-dose groups or placebo Subjects will then consume their assigned product daily for 6 weeks Subjects will undergo abdominal x-rays on study days 0 and 42 to assess transit time with each examination preceded by 6 days of radiopaque Sitz marker ingestion Subject diaries will be used to collect bowel movement frequency stool consistency concomitant medications and adverse events each day during the trial Stool samples will be collected at baseline and end of study to assess fecal probiotic count PAC-QOL WCS and GSRS questionnaires will be administered at baseline and day 42 24-hour food recalls will be administered at day 0 and 42 and the following parameters will be assessed total calories carbohydrate fat protein fiber and liquid intake Weekly physical activity recalls will be completed
Detailed Description:
Primary Endpoint Whole gut transit time
The primary endpoint of this clinical trial is whole gut transit time which will be assessed using abdominal x-rays supine anteroposterior kidney-ureter-bladder KUB on days 0 and 42 Each subject will ingest 24 radiopaque Sitz markers each day for 6 consecutive days at the same time of the day prior to abdominal x-rays on days 0 and 42 also taken at the same time of the day that the markers were taken The number of markers present in the right left and rectosigmoid colon will be summed to yield a total marker count Whole gut transit time will be calculated using the classic film estimate as described in the following formula
WGTT ni x tN 19 20
where ni is the number of markers observed on x-ray t is the time between marker ingestions in hours and N is the total number of markers ingested each day Thus in this study tN equals 1 24 markers per capsule24 hours between marker ingestions and WGTT is therefore equal to the total marker count 19 20
Marker counts will be identified by a single radiologist at each site who will remain blinded to subject treatment assignment
The methodology above is safe noninvasive and the two abdominal x-rays required for this study collectively expose each subject to radiation doses of approximately 140 millirem equivalent to 14 millisievert The overall lifetime risk that this radiation dosage may cause cancer is approximately 1 in 4000 for women aged 18 years 1 in 6000 for men aged 18 years 1 in 20000 for women aged 70 years and 1 in 25000 for men aged 70 years Similar abdominal x-ray methodology has been utilized in similar studies in adults aged 18 years and older 21 22
Secondary Endpoint Patient Assessment of Constipation Quality of Life PAC-QoL The PAC-QoL Appendix A is a 28-question survey that measures the impact that constipation has on daily life over the past 2 weeks The questions are comprised of four subscales worries and concerns physical discomfort psychosocial discomfort and satisfaction and an overall scale Multinational studies have demonstrated that the PAC-QoL is internally consistent reproducible valid and responsive to improvements over time 23 Subjects will complete the PAC-QoL at days 0 and 42
Secondary Endpoint Wexner Constipation Score WCS The Wexner Constipation Score WCS Appendix B is an 8-question survey that assesses frequency of bowel movements straining incomplete evacuation abdominal pain time needed for defecation assistance for defecation unsuccessful attempts and duration of constipation The WCS is a validated questionnaire since WCS scores correlate well with objective physiologic findings in constipated patients 24 Subjects will complete the WCS at days 0 and 42
Secondary Endpoint Gastrointestinal Symptom Rating Scale GSRS The GSRS Appendix C is a 15-item instrument designed to assess common GI symptoms 25 It has five subscales reflux diarrhea constipation indigestion and abdominal pain with subscale scores ranging from 1 no discomfort to 7 severe discomfort Higher scores represent higher symptom burden Subjects will complete the GSRS at days 0 and 42
Secondary Endpoint Stool frequency Throughout the study subjects will record the number of defecations per day in a diary throughout the study The stool frequency endpoint will be the absolute change in weekly stools in each group from the second week of the run-in period to the sixth study week
Secondary Endpoint Stool Consistency Stool consistency will be rated with the Bristol Stool Scale Form 26 Appendix D Subjects will grade each stool using a daily diary throughout the study The stool consistency endpoint will be the mean change in each group from the second week of the run-in period to the sixth study week
Secondary Endpoint Fecal Probiotic Count Stool samples will be collected at baseline and end of study to assess fecal probiotic count via live culture which will include total lactobacillis count and total bifidobacterium count At the Day 0 visit following randomization subjects will be provided two separate stool collection kits-one to be used at baseline and one to be used at the end of the supplementation period
After receipt of the kits subjects must provide the first stool sample before taking the first dose of study product regardless of the length of time needed to have a bowel movement The stool sample can be provided at the study site on Day 0 or the subject may collect their first stool thereafter and ship the sample in a provided refrigerated container to the laboratory for analysis Once the first stool sample is provided the subject may then begin consuming study product
During the final 3 days of the supplementation period ie Day 40 41 or 42 subjects must provide another stool sample and ship the sample in a provided refrigerated container to the laboratory for analysis This must be completed before returning to the site for the Day 42 assessments
Secondary Endpoint Adverse Events Adverse events AEs will be assessed throughout this clinical study The main safety endpoint will be the proportion of subjects in each group that report one of more AEs at any time during the study Please see Section 6 for additional details on the AE assessment
Ancillary Outcome International Physical Activity Questionnaire IPAQ-short version The International Physical Activity Questionnaire IPAQ-short version is a validated questionnaire suitable for quantifying physical activity levels in adults Appendix E 27
Ancillary Outcome 24-hour Food Recall A 24-hour food recall will be completed in order to quantify total calories carbohydrate g fat g protein g fiber g and liquid intake ml The food recall must take place on a weekday Monday through Thursday Subjects must record all foods and beverages consumed as well as the quantity of each recorded as weight or volume
Ancillary Outcome Concomitant medication use Throughout the study subjects will record use of any concomitant medication and if required the need for rescue medication each day in a diary
The primary endpoint of this clinical trial is whole gut transit time which will be assessed using abdominal x-rays supine anteroposterior kidney-ureter-bladder KUB on days 0 and 42 Each subject will ingest 24 radiopaque Sitz markers each day for 6 consecutive days at the same time of the day prior to abdominal x-rays on days 0 and 42 also taken at the same time of the day that the markers were taken The number of markers present in the right left and rectosigmoid colon will be summed to yield a total marker count Whole gut transit time will be calculated using the classic film estimate as described in the following formula
WGTT ni x tN 19 20
where ni is the number of markers observed on x-ray t is the time between marker ingestions in hours and N is the total number of markers ingested each day Thus in this study tN equals 1 24 markers per capsule24 hours between marker ingestions and WGTT is therefore equal to the total marker count 19 20
Marker counts will be identified by a single radiologist at each site who will remain blinded to subject treatment assignment
The methodology above is safe noninvasive and the two abdominal x-rays required for this study collectively expose each subject to radiation doses of approximately 140 millirem equivalent to 14 millisievert The overall lifetime risk that this radiation dosage may cause cancer is approximately 1 in 4000 for women aged 18 years 1 in 6000 for men aged 18 years 1 in 20000 for women aged 70 years and 1 in 25000 for men aged 70 years Similar abdominal x-ray methodology has been utilized in similar studies in adults aged 18 years and older 21 22
Secondary Endpoint Patient Assessment of Constipation Quality of Life PAC-QoL The PAC-QoL Appendix A is a 28-question survey that measures the impact that constipation has on daily life over the past 2 weeks The questions are comprised of four subscales worries and concerns physical discomfort psychosocial discomfort and satisfaction and an overall scale Multinational studies have demonstrated that the PAC-QoL is internally consistent reproducible valid and responsive to improvements over time 23 Subjects will complete the PAC-QoL at days 0 and 42
Secondary Endpoint Wexner Constipation Score WCS The Wexner Constipation Score WCS Appendix B is an 8-question survey that assesses frequency of bowel movements straining incomplete evacuation abdominal pain time needed for defecation assistance for defecation unsuccessful attempts and duration of constipation The WCS is a validated questionnaire since WCS scores correlate well with objective physiologic findings in constipated patients 24 Subjects will complete the WCS at days 0 and 42
Secondary Endpoint Gastrointestinal Symptom Rating Scale GSRS The GSRS Appendix C is a 15-item instrument designed to assess common GI symptoms 25 It has five subscales reflux diarrhea constipation indigestion and abdominal pain with subscale scores ranging from 1 no discomfort to 7 severe discomfort Higher scores represent higher symptom burden Subjects will complete the GSRS at days 0 and 42
Secondary Endpoint Stool frequency Throughout the study subjects will record the number of defecations per day in a diary throughout the study The stool frequency endpoint will be the absolute change in weekly stools in each group from the second week of the run-in period to the sixth study week
Secondary Endpoint Stool Consistency Stool consistency will be rated with the Bristol Stool Scale Form 26 Appendix D Subjects will grade each stool using a daily diary throughout the study The stool consistency endpoint will be the mean change in each group from the second week of the run-in period to the sixth study week
Secondary Endpoint Fecal Probiotic Count Stool samples will be collected at baseline and end of study to assess fecal probiotic count via live culture which will include total lactobacillis count and total bifidobacterium count At the Day 0 visit following randomization subjects will be provided two separate stool collection kits-one to be used at baseline and one to be used at the end of the supplementation period
After receipt of the kits subjects must provide the first stool sample before taking the first dose of study product regardless of the length of time needed to have a bowel movement The stool sample can be provided at the study site on Day 0 or the subject may collect their first stool thereafter and ship the sample in a provided refrigerated container to the laboratory for analysis Once the first stool sample is provided the subject may then begin consuming study product
During the final 3 days of the supplementation period ie Day 40 41 or 42 subjects must provide another stool sample and ship the sample in a provided refrigerated container to the laboratory for analysis This must be completed before returning to the site for the Day 42 assessments
Secondary Endpoint Adverse Events Adverse events AEs will be assessed throughout this clinical study The main safety endpoint will be the proportion of subjects in each group that report one of more AEs at any time during the study Please see Section 6 for additional details on the AE assessment
Ancillary Outcome International Physical Activity Questionnaire IPAQ-short version The International Physical Activity Questionnaire IPAQ-short version is a validated questionnaire suitable for quantifying physical activity levels in adults Appendix E 27
Ancillary Outcome 24-hour Food Recall A 24-hour food recall will be completed in order to quantify total calories carbohydrate g fat g protein g fiber g and liquid intake ml The food recall must take place on a weekday Monday through Thursday Subjects must record all foods and beverages consumed as well as the quantity of each recorded as weight or volume
Ancillary Outcome Concomitant medication use Throughout the study subjects will record use of any concomitant medication and if required the need for rescue medication each day in a diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None