Open Label Clinical Trial on the Efficacy of a Probiotic Strain of Bifidobacterium Longum 35624 (Alflorex®) in Functional Gastrointestinal Disorders (GFRS) in Children 8 to 18 Years of Age.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in IBS symptom severity assessed by an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS)
研究概览
简要总结
The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) to accurately reflect the pediatric population using the aid of the validated Numeric Pain Rating Scale (NRS-II) in children with Functional Gastrointestinal Disorders (FGIDs).
详细描述
This is an open label study to assess the safety and effectiveness of Bifidobacterium longum 35624® Alflorex® when consumed once daily by children with Functional Gastrointestinal Disorders (FGIDs). The 12-week intervention study will be conducted in 63 non-coeliac children aged 8 to 18 years old with an FGID who experience at least two episodes of abdominal pain per week. The study will consist of 5 visits over a 14 week period commencing with a screening visit. The second visit will be the baseline (start of intervention), followed by third (mid-intervention), fourth (end of treatment) and fifth (follow up) visit. Questionnaires will be administered from the second to the fifth visit. A blood sample will be taken before treatment to rule out coeliac disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-18 years
- •ROME IV diagnostic criteria Pediatric functional digestive disorders: in children and adolescents. H
- •Functional abdominal pain disorders H2a. Functional dyspepsia H2b. Irritable bowel syndrome H2d. Functional abdominal pain not otherwise specified H
- •Functional defecation disorders H3a. Functional constipation H3b. Non-retentive fecal incontinence Meet the criteria during the last three months with the onset symptoms for at least six months before diagnosis
- •IBS rated moderate to severe according to GSRS-IBS score (Spanish / LA)
- •At least two episodes of abdominal pain per week
- •No consumption of probiotics at least two weeks before baseline measurements (but preferably four weeks);
- •Dad, Mom, or Guardian able to understand the protocol;
- •Be willing to maintain stable dietary habits throughout the study period;
- •Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator;
- •Signature of Informed Consent.
排除标准
- •Children with systemic, organic or metabolic diseases, immunosuppression, different from IBS
- •Previous major abdominal surgery;
- •Consumption of proton pump inhibitors, H2 antagonists;
- •Consumption of probiotics in the two weeks before baseline measurements;
- •Are less than 8 or older than 18 years of age at the time of consent;
- •Subject who has been on antibiotics during the past 3 months;
- •Subjects who have not had at least two episodes of abdominal pain per week;
- •Subject with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection;
- •Subject who are coeliac or lactose intolerant;
- •Known allergy to any of the components of the test product;
- •Participation in a clinical study with an investigational product within 60 days before screening, or plans to participate in another study during the study period;
- •Subject has a history of non-compliance;
- •Use of dietary supplements or other fermented foods that contain live bacteria.
- •Pregnant or lactating females.
结局指标
主要结局
Change in IBS symptom severity assessed by an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS)
时间窗: Change from baseline, assessed at 6 and 12 weeks of supplement intake
The IBS-SSS measures symptom severity in IBS patients and is a reliable and validated questionnaire taking into account the composite score of abdominal pain, number of days with abdominal pain, bloating/distention, satisfaction with bowel habits and IBS-related quality of life. For this study, an adapted version was used in conjunction with the NRS-11 pain scale for the purposes of accurately capturing the response of a pediatric population. The NRS-11 pain scale goes from 0-10 with 0 indicating "no pain" and 10 indicating "very severe pain."
Change in abdominal pain assessed by the Numeric Rating Scale for pain
时间窗: Change from baseline, assessed at 6 and 12 weeks of supplement intake
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain which goes from 0 (no pain) to 10 (worst pain)
次要结局
- Change in quality of life assessed by the Irritable Bowel Syndrome-Quality of Life questionnaire(Change from baseline, assessed at 6 and 12 weeks of supplement intake)
- Change in stool consistency assessed using the Bristol Stool Form Scale(Change from baseline, assessed at 6 and 12 weeks of supplement intake)
- Change in stool frequency(Change from baseline, assessed at 6 and 12 weeks of supplement intake)
- Change in days absent from school(Change from baseline, assessed at 6 and 12 weeks of supplement intake)