Gut-Directed Hypnotherapy vs. Probiotics in Children and Adolescents With Irritable Bowel Syndrome and Functional Abdominal Pain - A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in number of days with pain/discomfort
研究概览
简要总结
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).
详细描述
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 children's 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 Go/No-Go test) and measuring of cortisol awakening response (CAR) are used to study the function of autonomic nerve system and stress-level/tolerance of the study population.
The investigators hypothesize:
- a significant decrease in number of days with pain/discomfort in both intervention groups (GDH, NS) as compared to the control group (active waiting-list control group)
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 6 and 17
- •participants should fulfill following criteria for functional abdominal pain (FAP) or irritable bowel syndrome (IBS) according to Rome III Consensus
- •medical report from a gastroenterologist about absence of an organic reason for the gastrointestinal complaints
排除标准
- •organic reason for abdominal pain is diagnosed (e.g. celiac disease, inflammable bowel diseases)
- •children fulfill criteria for abdominal migraine
- •other acute or chronic disorders of the gastrointestinal, cardiovascular or peripheral nervous system are present
- •inability to follow instructions
研究组 & 干预措施
Gut-Directed Hypnotherapy (GDH)
Gut-Directed Hypnotherapy on a daily basis (20 min each day, at least 4 times/week)
干预措施: Gut-Directed Hypnotherapy (Behavioral)
Gut-Directed Hypnotherapy (GDH)
Gut-Directed Hypnotherapy on a daily basis (20 min each day, at least 4 times/week)
干预措施: Self-Monitoring (Behavioral)
Probiotic (NS)
Nutritional supplement SymbioLact B once a day diluted in water or tea
干预措施: Nutritional Supplement (Dietary Supplement)
Probiotic (NS)
Nutritional supplement SymbioLact B once a day diluted in water or tea
干预措施: Self-Monitoring (Behavioral)
Active Controls (AC)
AC group keeps a symptom dairy (self-monitoring)
干预措施: Self-Monitoring (Behavioral)
结局指标
主要结局
Change in number of days with pain/discomfort
时间窗: baseline, at week 10 and at 3 months follow-up
次要结局
- Change in parental report on gastrointestinal symptoms (Abdominal Pain Index (API))(baseline, at week 10 and at 3 months follow-up)
- Change in pain related disability (Pediatric Pain Disability Index (P-PDI))(baseline, at week 10 and at 3 months follow-up)
- Change in somatic complaints (Children's Somatization Inventory (CSI))(baseline, at week 10 and at 3 months follow-up)
- Change in health-related quality of life (KINDL-R Questionnaire)(baseline, at week 10 and at 3 months follow-up)
- Change in pain-related coping (Pediatric Pain Coping Inventory (PPCI))(baseline, at week 10 and at 3 months follow-up)
- Change in emotional and behavioural problems (Child Behaviour Checklist (CBCL))(baseline, at week 10 and at 3 months follow-up)
- Change in heart rate variability(baseline and at week 10)
- Change in cortisol awakening response (amount of cortisol in saliva, nmol/l)(baseline and at week 10)
- Change in self-reported pain intensity (Visual Analog Scale)(baseline, at week 10 and at 3 months follow-up)
- Change in self-reported pain duration (hours per day)(baseline, at week 10 and at 3 months follow-up)