A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Detection of inflammatory cytokine markers in ISF.
研究概览
简要总结
This project aims to study whether regular skin massage in babies induces cutaneous inflammation and whether this inflammatory response is amplified in those receiving daily (vs bi-weekly or no) skin massage over an 8 week period. Specifically, it aims to:
- Establish if massage increases /decreases immune signals in the skin.
- Clarify if the effects of massage are enhanced with the frequency of massage. 3.) Assess changes in skin biology as a consequence of skin massage. 4.) Determine if massage impacts skin barrier function in the early years of life.
详细描述
Massaging the skin is thought to be beneficial to facilitate bonding between babies and their caregivers. Evidence shows that it can help blood flow and may also positively impact the baby's immune system. However, this has not been researched in detail before. In our study, we aim to understand how the skin immune system reacts to massage. We aim to establish if regular skin massage induces cutaneous immune system changes measured through pro-inflammatory cytokines in interstitial fluid (ISF), and whether this response is amplified in those receiving daily (vs bi-weekly or no) skin massage over an 8 week period.
How skin massage influences the cutaneous immune system has not been investigated to date. The study will aim to address the following hypotheses:
- Regular skin massage generates immune "warning" signals (such as cytokines), the precondition of the skin during healthy development, more so in those who have massaged daily (compared to no massage and bi-weekly massage).
- Skin massage enhances skin barrier function and bacterial diversity of the skin.
The study is split into two parts. In part 1, the ISF device will be piloted in the first 9 healthy babies enrolled in the study to optimise the pressure and length of time the device is used for. Participants will be invited to attend 1 visit to the Clinical Research Facility at St Thomas' Hospital, lasting approximately 1 hour for this non-invasive collection of skin fluid and skin barrier measurements. We can offer allergy testing to house dust mite, peanut, egg and milk for your baby, if you are interested.
Part 2 is a randomised controlled trial that will investigate how regular skin massage impacts the immune system in 100 healthy baby's. Participants will be randomly allocated to 1 of 3 groups for the 8 week period:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy babies born at term up to 6 months old
- •Ability of parents/guardians/caregivers to provide written informed consent for study participation
- •Willingness of parents/guardians/caregivers to comply with all study requirements.
排除标准
- •Parents/guardians/caregivers unable to give informed consent.
- •Personal history of inflammatory skin disease (in particular atopic dermatitis)
- •Active involvement in another interventional research study
研究组 & 干预措施
No application of product and no massage
No application of product and no massage.
Twice-Weekly Massage with Product
Application of product containing oil- and aqueous-based components + skin massage twice a week
干预措施: Skin Massage with Product (Other)
Daily Massage with Product
Application of product containing oil- and aqueous-based components + skin massage daily
干预措施: Skin Massage with Product (Other)
结局指标
主要结局
Detection of inflammatory cytokine markers in ISF.
时间窗: 8 weeks
The release of allergy-related and barrier-related soluble mediators such as IL-10 and TGF-β as well as other Th1/Th2 and other inflammatory cytokines.
次要结局
- Detection of skin biology changes in ISF using genetic profiling (RNA sequencing) and proteomics.(8 weeks)
- Detection of changes in barrier function(8 weeks)
- To measure specific IgE to foods and aeroallergens(8 weeks)
- To detect signals of skin microbiota e.g. bacterial diversity in addition to specific strains such as Staphylococci.(8 weeks)
