Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02613078
Status:
UNKNOWN
Last Update Posted:
2016-03-03
First Post:
2015-10-23
Brief Title:
Hypnotherapy vs Probiotics in Children With IBS and Functional Abdominal Pain
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Gut-Directed Hypnotherapy vs Probiotics in Children and Adolescents With Irritable Bowel Syndrome and Functional Abdominal Pain - A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2016-02
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:
Current study aims to investigate the influence of gut-directed hypnotherapy and probiotic nutritional supplement SymbioLact B on gastrointestinal symptoms in children with functional abdominal pain or irritable bowel syndrome compared to self-observation only The study also includes collection of psychometric data emotional and behavioral problems pain coping strategies data on activity of the autonomous nerve system as measured by heart rate variability and data on stress response saliva cortisol levels
Detailed Description:
Children with irritable bowel syndrome IBS or other pain-related functional gastrointestinal disorders FGIDs such as functional abdominal pain FAP represent a considerable part of visits to pediatric practitioners These disorders do not only decrease the quality of life but also increase the risk of symptom persistence and comorbid mental issues in adulthood As etiology and pathophysiology of FGIDs are still a matter of research several approaches of managing of FGIDs are commonly used dietary interventions probiotics drug treatment psychosocial interventions While recent meta-analyses showed almost no favorable effects of dietary interventions and drug treatments 5-HT4 receptor agonists antispasmodic and anti-diarrheal agents antibiotics in children with FGIDs probiotics and psychosocial interventions remain promising regarding effective symptom relief Several randomized controlled trials RCT have shown a beneficial effect of both gut directed hypnosis GDH and probiotics To our knowledge there are no studies that investigated both types of intervention in comparison to a control group intervention This study aims to fill this gap
In a prospective randomized study the investigators aim to obtain preliminary results about the impact of gut-directed hypnotherapy GDH modified for self-practicing and probiotic nutritional supplement NS on symptoms in children with pain-related FGIDs IBS and FAP This is going to be measured by the mean of number of days the children experience no abdominal pain or discomfort Beside that the investigators plan to obtain data on abdominal pain intensity and duration and about the effects of above mentioned interventions on childrens health-related quality of life KINDL-R pain-related disability P-PDI their coping abilities PPCI and behavioural and emotional problems CBCL The information obtained from children as well as from parental perspective will allow more extensive models on mechanisms of change
Beyond psychometric instruments some well-established psychophysiological methods will be used Assessment of the heart rate variability under mental stress conditions Parametric GoNo-Go test and measuring of cortisol awakening response CAR are used to study the function of autonomic nerve system and stress-leveltolerance of the study population
The investigators hypothesize
1 a significant decrease in number of days with paindiscomfort in both intervention groups GDH NS as compared to the control group active waiting-list control group
2 that both types of intervention lead to an increase of quality of life and decrease of pain duration intensity and pain-related disability as compared to the control group
3 a decrease of physiological stress parameters as measured by heart rate variability HRV analysis cortisol awakening response CAR in both intervention groups as compared to the control group but more prominent in GDH group
The data of this pilot study will be used for further projects where the most promising intervention and research parameters will be investigated more detailed in a larger sample
Current study is regarded as a pilot and is conducted in order to obtain information about the efficacy of GDH and probiotic intervention in children with IBS or FAP as compared to reference group Based on our previous studies and data of literature the investigators expect to see moderate effect power of the primary outcome measure η²06 In order to detect a 50 improvement of symptoms during 4 week treatment with 80 power assuming α05 and using a 2 x 3 repeated measure design for the main analysis 51 participants should be included in the study Taking into account possible dropouts the investigators plan to recruit 60 children 20 children per group
Short description of study protocol Parents that are interested in the study after a first contact with the investigators will receive detailed informations about the study and a short anamnestic questionnaire After returning it they will be invited together with their children for the diagnostic appointment Visit I Inclusion into the study will be made based on the results of anamnestic interview as well as based on the reports from the responsible gastroenterologist regarding exclusion of other possible reason for the symptoms including organic disorder eg Celiac disease Participants and their parents will also receive all necessary information about goals of the study and methods used in the study as well as about possible health risks from applied interventions Informed consent is to be signed prior inclusion in the study After inclusion children and parents will be asked not to change any currently used medications or to undertake another treatment as well as not to change usual habits until the end of the follow-up period
Participants will be filling in diaries that will question about their symptoms once a day
During the first two weeks run-in period participants will only be keeping their symptom diaries This data will be used in later analysis as baseline data for comparison with any changes that will occur due to intervention The week three and four are regarded as wash-out period participants will be instructed to stop answering questions in diaries The investigators hypothesize that this will reduce the effect of self-monitoring when the treatment starts
At the end of week four children will be randomized into one of three groups based on computer generated table of random numbers each participant will be allocated either to a group practicing a gut-directed hypnosis or receiving a probiotic for the next four weeks SymbioLact B or reference group only symptom diaries Participants are randomized with an aspect ratio 111 Children will continue to keep the symptom diaries for another two weeks week 9 and 10 and will return them to the investigators during Visit II at the end of 10th week
Visits I and II will also be used to collect psychometric data from children and their parents as well as psychophysiological measures HRV Saliva samples should be collected at home participants will be provided with appropriate collection tubes as well as with detailed instructions on how to collect store and deliver samples to the investigation site Baseline saliva samples should be collected inside the first week and during week 10 in a morning before Visit II
For ethical reasons a second intervention can be chosen freely by the family after the follow-up period
Risks of the study A systematic review and meta-analysis of randomized clinical trials about the effects of probiotic in children with pain-related FGID as well as RCTs report seldom or no adverse effects from probiotics If appeared - most often in a form of gastroenteritis and vomiting - the adverse effects were comparable to those in a placebo group Based on previous studies of our group we expect no adverse events from gut directed hypnosis All adverse events in any group will be documented and reported
In a prospective randomized study the investigators aim to obtain preliminary results about the impact of gut-directed hypnotherapy GDH modified for self-practicing and probiotic nutritional supplement NS on symptoms in children with pain-related FGIDs IBS and FAP This is going to be measured by the mean of number of days the children experience no abdominal pain or discomfort Beside that the investigators plan to obtain data on abdominal pain intensity and duration and about the effects of above mentioned interventions on childrens health-related quality of life KINDL-R pain-related disability P-PDI their coping abilities PPCI and behavioural and emotional problems CBCL The information obtained from children as well as from parental perspective will allow more extensive models on mechanisms of change
Beyond psychometric instruments some well-established psychophysiological methods will be used Assessment of the heart rate variability under mental stress conditions Parametric GoNo-Go test and measuring of cortisol awakening response CAR are used to study the function of autonomic nerve system and stress-leveltolerance of the study population
The investigators hypothesize
1 a significant decrease in number of days with paindiscomfort in both intervention groups GDH NS as compared to the control group active waiting-list control group
2 that both types of intervention lead to an increase of quality of life and decrease of pain duration intensity and pain-related disability as compared to the control group
3 a decrease of physiological stress parameters as measured by heart rate variability HRV analysis cortisol awakening response CAR in both intervention groups as compared to the control group but more prominent in GDH group
The data of this pilot study will be used for further projects where the most promising intervention and research parameters will be investigated more detailed in a larger sample
Current study is regarded as a pilot and is conducted in order to obtain information about the efficacy of GDH and probiotic intervention in children with IBS or FAP as compared to reference group Based on our previous studies and data of literature the investigators expect to see moderate effect power of the primary outcome measure η²06 In order to detect a 50 improvement of symptoms during 4 week treatment with 80 power assuming α05 and using a 2 x 3 repeated measure design for the main analysis 51 participants should be included in the study Taking into account possible dropouts the investigators plan to recruit 60 children 20 children per group
Short description of study protocol Parents that are interested in the study after a first contact with the investigators will receive detailed informations about the study and a short anamnestic questionnaire After returning it they will be invited together with their children for the diagnostic appointment Visit I Inclusion into the study will be made based on the results of anamnestic interview as well as based on the reports from the responsible gastroenterologist regarding exclusion of other possible reason for the symptoms including organic disorder eg Celiac disease Participants and their parents will also receive all necessary information about goals of the study and methods used in the study as well as about possible health risks from applied interventions Informed consent is to be signed prior inclusion in the study After inclusion children and parents will be asked not to change any currently used medications or to undertake another treatment as well as not to change usual habits until the end of the follow-up period
Participants will be filling in diaries that will question about their symptoms once a day
During the first two weeks run-in period participants will only be keeping their symptom diaries This data will be used in later analysis as baseline data for comparison with any changes that will occur due to intervention The week three and four are regarded as wash-out period participants will be instructed to stop answering questions in diaries The investigators hypothesize that this will reduce the effect of self-monitoring when the treatment starts
At the end of week four children will be randomized into one of three groups based on computer generated table of random numbers each participant will be allocated either to a group practicing a gut-directed hypnosis or receiving a probiotic for the next four weeks SymbioLact B or reference group only symptom diaries Participants are randomized with an aspect ratio 111 Children will continue to keep the symptom diaries for another two weeks week 9 and 10 and will return them to the investigators during Visit II at the end of 10th week
Visits I and II will also be used to collect psychometric data from children and their parents as well as psychophysiological measures HRV Saliva samples should be collected at home participants will be provided with appropriate collection tubes as well as with detailed instructions on how to collect store and deliver samples to the investigation site Baseline saliva samples should be collected inside the first week and during week 10 in a morning before Visit II
For ethical reasons a second intervention can be chosen freely by the family after the follow-up period
Risks of the study A systematic review and meta-analysis of randomized clinical trials about the effects of probiotic in children with pain-related FGID as well as RCTs report seldom or no adverse effects from probiotics If appeared - most often in a form of gastroenteritis and vomiting - the adverse effects were comparable to those in a placebo group Based on previous studies of our group we expect no adverse events from gut directed hypnosis All adverse events in any group will be documented and reported
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